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NanoMaxx Ultrasound System User Guide

1. Transducer Xm 2D Color CPD type Clin Abd Vas C60n Abd Gyn Nrv OB L25n IMT Msk Nrv Sup Vas Ven L38n IMT MSK Nrv SmP Vas Ven P21n Abd Crd OB TX 0X KK KKK KOK KKK KK KK KK KK TX XK XK XKX X KK XKX X K X XXX Xx XK TX KKK KK KOK KKK KKK KKK XxX XxX x lt x lt X 1 Exam type abbreviations Abd Abdomen Crd Cardiac IMT Intima Media Thickness MSK Musculoskeletal Nrv Nerve OB Obstetrical SmP Small Parts Sup Superficial Vas Vascular Ven Venous 2 The optimization settings for 2D are Res Gen and Pen Transducer includes Tissue Harmonic Imaging For more information see Glossary on page 73 UJ 22 Imaging modes and exams available by transducer Chapter 4 Measurements and Calculations With the NanoMaxx ultrasound system you can take distance measurements on an image In the IMT also called Carotid IMT or CIMT exam you can also take measurements for calculations which save to a patient report Measurements are performed on frozen images For references used see Chapter 7 References 7 Measurements You can take measurements in any imaging mode and can save the image with the measurements displayed Figure 1 2D image with two measurements Working with calipers When measuring you work with calipers Results based on the calipers position appear at the bottom of the screen The results update as you reposition the calipers You can
2. What is the Spectrum of Current and Emerging Techniques for the Noninvasive Measurement of Atherosclerosis Journal of the American College of Cardiology June 4 2003 41 11 1886 1898 Measurement publications IMT Chapter 8 Specifications This chapter contains system and accessory specifications and standards The specifications for recommended peripherals are in the manufacturers instructions Supported transducers e Cl1n 8 5 MHz 6 ft 1 8 m C60n 5 2 MHz 5 5 ft 1 7 m e 25n 13 6 MHz 7 5 ft 2 3 m e L38n 10 5 MHz 5 5 ft 1 7 m e p21n 5 1 MHz 6 ft 1 8 m Imaging modes 2D 256 gray shades e Color power Doppler CPD 256 colors Color Doppler Color 256 colors Image storage Internal storage The number of images you can save depends on imaging mode and file format Accessories The following items are either included with or available for use on the ultrasound system Battery Carry case Dock Needle guide Power adapter Power supply e System AC power cord 10 ft 3 1 m e V Universal Stand Peripheral The following medical grade conforming to EN 60601 1 requirements product is available for use with the ultrasound system Black and white printer To order printer paper and other supplies or to find the local distributor contact Sony at www sony com digital photofinishing Manufacturer s instructions accompany each peripheral Temperature and hu
3. field at the top 2 Tap each character you want to enter A turns capital letters on or off for the next letter entered Aj displays and hides international characters Symbols displays symbols and punctuation Aaturns capital letters on and off Delete deletes the character right of the pointer e and gt reposition the pointer within text entered You can also tap in the text 3 Optional In forms navigate among text fields Tap Next to advance to the next field Tap Prev to return to the previous field 4 Tap Done 6 Preparing transducers Preparing transducers WARNING Some transducer sheaths contain natural rubber latex and talc which can cause allergic reactions in some individuals Refer to 21 CFR 801 437 User labeling for devices that contain natural rubber Some gels and sterilants can cause an allergic reaction on some individuals Caution To avoid damage to the transducer use only gels recommended by SonoSite Using gels other than the one recommended by SonoSite can damage the transducer and void the warranty If you have questions about gel compatibility contact SonoSite or your local representative SonoSite recommends that you clean transducers after each use See Cleaning and disinfecting transducers on page 29 Acoustic coupling gel must be used during exams Although most gels provide suitable acoustic coupling some gels are incompatible with
4. style folder structure e DICOM creates files readable by a DICOM reader 3 Select an image format for your export type For JPEG image format also select a JPEG compression A high compression has a smaller file size but less detail 4 For SiteLink export type select a sort order from the Sort By list The sort order specifies how exported files are organized To return to the previous screen tap Devices To specify AE title The AE title identifies your system with exported images that you import to a PACS archiver On the USB Devices setup page type a unique name for your system in the AE Title text box Default is NanoMAXX To include private tags If you use DICOM export type and a SonoSite software product include private tags on the images On the USB Devices setup page select Include private tags Note Because the tags may be incompatible with some earlier archivers keep this check box unselected unless you use SonoSite software products For more information see NanoMaxx System DICOM Conformance Statement 14 USB Devices setup Limitations of JPEG format When transferring or exporting images in JPEG format the system uses lossy compression Lossy compression may create images that have less absolute detail than BMP format and that don t render identically to the original images In some circumstances lossy compressed images may be inappropriate for clinical use For example i
5. 5 07 n Dim of Aaprt X cm Y cm PD usec 0 32 s PRF H2 5221 E P Pll max MPa 3 78 9 deqGPlli y cm V Focal Length FL cm R 0 ue 5 FL cm lIpa 3 Mlmax W cm 602 0 E Control 1 Exam Type Msk a Nrv SS Control 2 2D Optimization Pen ox 2 Control 3 Depth 4 7 cm S S Control 4 MB Multi Beam amp Off a This index is not required for this operating mode value is 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition since the global maximum index value is not reported for the reason listed Reference Global Maximum Index Value line Data are not applicable for this transducer mode Chapter 6 Safety 57 Ayayes Table 15 Transducer Model L38n 10 5 Operating Mode CPD Color TIS TIB Index Label MI Non scan TIC Scan Non scan AaprtS1 Aaprt gt 1 Global Maximum Index Value 1 5 1 2 b Pr3 MPa 3 21 Wo mW 92 67 E min of W 5 z1 l4 3 21 mW 3 5 Z cm lt z cm ae a E Sm SP 2v lne cm lt fe MHz 4 79 4 79 Dim of Aaprt X cm 0 42 Y cm 0 4 PD usec 0 55 S PRF H2 13705 E D Pllmax MPa 3 66 SO deqg Pllmax cm m Focal Length FL cm 1 16 E FLy cm 2 5
6. See To configure the system for a printer on page 12 2 Do one of the following Inthe patient list review the patient exam s images Tap Print when the image appears Freeze the image and tap Print To print multiple images 1 Verify that a printer is selected See To configure the system for a printer on page 12 2 Do one of the following e Print all images for multiple patient exams Select one or more patient exams in the patient list Then tap Print Print all images for one patient exam Highlight the patient exam in the patient list and tap Print Each image appears briefly on screen while printing To export patient exams to a USB storage device A USB storage device is for temporary storage of images Patient exams should be archived regularly To specify file format and AE title see USB Devices setup on page 13 A patient exam must be ended before you can export its images See To end the exam on page 18 Exporting large amounts of data can take as long as a few hours depending on compression file type file size and number of files To avoid this issue export data frequently for example after each patient exam or at the end of each day 1 Insert the USB storage device See Inserting and removing USB storage devices on page 4 2 Inthe patient list select the patient exams you want to export 3 Tap Exp USB A list of USB devices appears 4 Select the USB storage d
7. lpa 3 M max W cm 525 8 Nl Control 1 Mode CPD or CPD or 2 Color Color E Control 2 Exam Type SmP SmP o Msk Msk X Control 3 2D Optimization Pen Res g V Control 4 Depth 2 0cm 20 cm e Control 5 Color Box Default Default a This index is not required for this operating mode value is lt 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition since the global maximum index value is not reported for the reason listed Reference Global Maximum Index Value line Data are not applicable for this transducer mode 58 Table 16 Transducer Model P21n 5 1 Operating Mode 2D TIS TIB Index Label MI Non scan TIC Scan Non scan AaprtS1 Aaprt gt 1 Global Maximum Index Value 1 4 a 2 1 Pr3 MPa 1 974 Wo mW n 158 3 E min of W 5 z4 a 3 24 mW 3 5 Z cm lt z cm itk Mae Sg P i a dae cm 4 R MHZ 1 94 n m 1 90 Dim of Aaprt X cm 0 59 Y cm 1 3 PD usec 0 924 S PRF H2 5556 E p PII MPa 2 39 o deg Pllmax cm Focal Length FL cm 1 55 FL cm 5 5 IpA 3 Mlmax W cm 180 5 9 Control 1 Exam Type Abd Abd 5 Control 2 2D Optimization Res Gen 2s Control 3 Depth 7 5 cm 4 7 cm s S Control 4 THI On On 6 Contr
8. MI See mechanical index MI and thermal index TI National Television Standards Committee A video format setting See also PAL Phase Alternating Line A video format setting See also NTSC A transducer designed primarily for cardiac scanning Forms a sector image by electronically steering the beam direction and focus Glossary 73 K esso r 74 skinline SonoHD imaging technology SonoMB technology thermal index TI TIB bone thermal index TIC cranial bone thermal index TIS soft tissue thermal index Tissue Harmonic Imaging transducer A depth on the display that corresponds to the skin transducer interface A subset of the 2D imaging mode in which the 2D image is enhanced by reducing speckle noise artifact at tissue margins and improving contrast resolution by reducing artifacts and improving visualization of texture patterns within the image A subset of the 2D imaging mode in which the 2D image is enhanced by looking at a target from three angles and then merging or averaging the scanned data together to improve overall image quality and in parallel reducing noise and artifacts The ratio of total acoustic power to the acoustic power required to raise tissue temperature by 1 C under defined assumptions See Chapter 6 Safety for a more complete description of TI A thermal index for applications in which the ultrasound beam passes through soft tissue and a focal region is in the
9. See instructions included with the stand or printer 2 On the Connectivity setup page select the printer in the Printer list 3 Select the video mode for your region NTSC or PAL To receive storage alerts On the Connectivity setup page select Internal Storage Capacity Alert The system displays a message if internal storage is near capacity when you end an exam Date and Time setup To set the date and time On the Date and Time setup page do the following Inthe Date box type the current date See Entering text on page 6 Inthe Time box type the current time in 24 hour format hours and minutes Display Information setup On the Display Information setup page you can specify which details appear on screen during imaging You can select check boxes in the following sections Patient Header Information from the patient information form See Patient information form on page 18 Mode Data Imaging information System Status Power battery connectivity and similar information Presets setup The Presets setup page has settings for general preferences You can select from the following lists and can calibrate the touchscreen Depth Markers Type 1 displays unnumbered markers with the maximum depth number in the lower right screen Type 2 displays markers with numbers Thermal Index You can select TIS TIB or TIC The default setting is based on exam type OB is TIB and all othe
10. Select the setup page from the Page list Tap Previous or Next until the page appears With the Page list highlighted press the knob Turn the knob to highlight the page and then press the knob To return to imaging from a setup page tap Done Restoring default settings To restore default settings for a setup page On the setup page tap Reset To restore all default settings 1 Turn the system off 2 Connect the system to AC power See To operate the system using AC power on page 3 3 While pressing down the knob press and release the power switch Release the knob after two beeps The system beeps several times Administration setup On the Administration setup page you can configure the system to require users to log in and enter passwords Required login helps protect patient data You can also add and delete users change passwords import and export user accounts and display the Event log Security settings WARNING Health care providers who maintain or transmit health information are required by the Health Insurance Portability and Accountability Act HIPAA of 1996 and the European Union Data Protection Directive 95 46 EC to implement appropriate procedures to ensure the integrity and confidentiality of information to protect against any reasonably anticipated threats or hazards to the security or integrity of the information or unauthorized uses or disclosures of the informati
11. and the image with the measurement displayed saves to internal storage 6 Exit the measurement by tapping one of the following Unfreeze to return to live imaging Clear Calc to clear the measurement from the screen allowing additional measurements on the image Patient report The patient report contains calculation results and patient information for the exam You can display the patient report during or after the exam The value for a calculation appears only if you performed and saved the calculation Calculation values that are out of range are indicated by the number sign and are not included in derived calculations for example mean To display the patient report 1 Tap More and select Report 2 To display additional pages tap and gt To exit the patient report and return to imaging tap Done To delete a measurement result from the patient report 1 Inthe patient report tap the measurement result The measurement result is highlighted green 2 Tap Delete 26 Calculations IMT exam Chapter 5 Troubleshooting and Maintenance This chapter contains information to help correct problems with system operation to enter a software license and to take proper care of the system transducer and accessories Troubleshooting If you encounter difficulty with the system use the following list to help troubleshoot the problem If the problem persists contact SonoSite Technical Support S
12. bending or stooping Minimize reaching and twisting Use a bed that is height adjustable Position the patient as close to you as possible Face forward Avoid twisting your head or body Move your entire body front to back and position your scanning arm next to or slightly in front of you Stand for difficult exams to minimize reaching Position the ultrasound system directly in front of you Promote comfortable shoulder and arm postures Keep your elbow close to your side Relax your shoulders in a level position Support your arm using a support cushion or pillow or rest it on the bed Promote comfortable hand wrist and finger postures Hold the transducer lightly in your fingers Minimize the pressure applied on the patient Keep your wrist in a straight position Take breaks exercise and vary activities Minimizing scanning time and taking breaks can effectively allow your body to recover from physical activity and help you avoid MSDs Some ultrasound tasks may require longer or more frequent breaks However simply changing tasks can help some muscle groups relax while others remain or become active Work efficiently by using the software and hardware features correctly Keep moving Avoid sustaining the same posture by varying your head neck body arm and leg positions Targeted exercises can strengthen muscle groups which may help you avoid MSDs Contact a qualified health pro
13. cssscsssscssecsssecssesssecssscsssccssecsscsssseessecsnsceseeesseess 72 HIPAA standard 5t Stereo a 72 Glossary vi Introduction This NanoMaxx Ultrasound System User Guide provides information on preparing and using the NanoMaxx ultrasound system and on cleaning and disinfecting the system and transducers It also provides system specifications and safety and acoustic output information The user guide is for a reader familiar with ultrasound techniques It does not provide training in sonography or clinical practices Before using the system you must have ultrasound training See the applicable SonoSite accessory user guide for information on using accessories and peripherals See the manufacturer s instructions for specific information about peripherals Conventions The user guide follows these conventions A WARNING describes precautions necessary to prevent injury or loss of life A Caution describes precautions necessary to protect the products Numbered steps in procedures must be performed in order tems in bulleted lists do not require a sequence e Single step procedures begin with Symbols and terms used on the system and transducer are explained in Chapter 1 Chapter 6 and Glossary Customer comments Questions and comments are encouraged SonoSite is interested in your feedback regarding the system and the user guide Please call SonoSite at 888 482 9449 in the US Outside
14. have two sets of calipers and can switch from one set to another repositioning them as needed Each set shows the measurement result The active calipers and measurement result are highlighted green A measurement is complete when you finish moving its calipers For an accurate measurement you must accurately place the calipers To switch the active calipers Do one of the following To switch the active caliper within a set tap Select To switch the active set tap Switch A B To place calipers more precisely Do any of the following Adjust the display for maximum sharpness e Use leading edges closest to the transducer or borders for starting and stopping points Maintain a consistent transducer orientation for each type of measurement Make sure that the area of interest fills as much of the screen as possible Minimize the depth or zoom Calibrate the touchscreen See To calibrate the touchscreen on page 13 Measuring Distance is measured in centimeters Chapter 4 Measurements and Calculations 23 sjueaulaJnseeiw To take a measurement 1 Ona frozen image tap i Calipers A set of calipers appears connected by a dotted line and labelled A 2 Position the caliper where desired a Press the knob to set its behavior e Left Right for left or right movement e Up Down for up or down movement The setting appears on the control next to the knob b Turnthe knob Press it as
15. immediate vicinity of bone A thermal index for applications in which the ultrasound beam passes through bone near the beam entrance into the body A thermal index related to soft tissues Transmits at one frequency and receives at a higher harmonic frequency to reduce noise and clutter and improve resolution A device that transforms one form of energy into another form of energy Ultrasound transducers contain piezoelectric elements which when excited electrically emit acoustic energy When the acoustic energy is transmitted into the body it travels until it encounters an interface or change in tissue properties At the interface an echo is formed that returns to the transducer where this acoustic energy is transformed into electrical energy processed and displayed as anatomical information Abbreviations Abbreviations in User Interface Abbreviation Definition Abd Abdomen Crd Cardiac Gen General an optimization setting IMT Intima Media Thickness MB SonoMB MI Mechanical Index Msk Musculoskeletal Nrv Nerve OB Obstetrical Pen Penetration an optimization setting Plaq Plaque Res Resolution an optimization setting SmP Small Parts Sup Superficial THI Tissue Harmonic Imaging TI Thermal Index Vas Vascular Ven Venous Glossary 75 Auesso 5 76 Index Numerics 2D imaging 15 A abbreviations 75 abdominal intended uses 7 accessories list 71 acoustic measurement precision 63 acousti
16. interaction among the operator the ultrasound system and the transducer When using an ultrasound system as with many similar physical activities you may experience occasional discomfort in your hands fingers arms shoulders eyes back or other parts of your body However if you experience symptoms such as constant or recurring discomfort pain throbbing aching tingling numbness burning sensation or stiffness promptly see a qualified health professional Such symptoms can be linked with musculoskeletal disorders MSDs MSDs can be painful and may result in potentially disabling injuries to the nerves muscles tendons or other parts of the body Examples of MSDs include carpal tunnel syndrome and tendonitis While researchers are not able to definitively answer many questions about MSDs there is a general agreement that certain factors are associated with their occurrence including preexisting medical and physical conditions overall health equipment and body position while doing work frequency of work duration of work and other physical activities that may facilitate the onset of MSDs This section provides guidelines that may help you work more comfortably and may reduce your risk of MSDs f a Magnavita N L Bevilacqua P Mirk A Fileni and N Castellino Work related Musculoskeletal Complaints in Sonologists Occupational Environmental Medicine 41 11 1999 981 988 b Craig M Sonography An Occupationa
17. license key During the grace period all system functions are available After the grace period the system is not usable until you enter a valid license key Grace period time is not used while the system is off or asleep Grace period time remaining appears on the license update screen Caution After the grace period expires all system functions except licensing are unavailable until a valid license key is entered To obtain a license key for your software contact SonoSite Technical Support See SonoSite Technical Support on page vii You need to provide the following information See System Information setup on page 13 Name ofinstitution installing the software Serial number on bottom of system PCBA serial number ARM version for system software or transducer package version for transducer software Chapter 5 Troubleshooting and Maintenance 27 Bunoouse qnoJ After you obtain a license key you must enter it into the system On occasion a software upgrade may be required SonoSite provides a USB device containing the software To enter a license key 1 Turn on the system The license update screen appears 2 Enter the license key in the Enter license key field 3 Tap Done on screen If you entered a valid license key but the license update screen appears verify that you entered the license key correctly If the license update screen still appears contact SonoSite Technical Supp
18. necessary to reset its behavior c Tap Select The second caliper becomes active 3 Position the second caliper where desired 4 If you want an additional set of calipers tap i Caliper A set of calipers labelled B appears Position the calipers where desired 5 Optional Tap Save The image saves with the measurements displayed To delete or edit a measurement With the measurement active highlighted do one of the following e To delete the measurement tap X Delete To delete all measurements tap Delete All To edit reposition the calipers where desired If the measurement is unavailable tap Back to reach the proper screen 24 Calculations IMT exam Calculations IMT exam Measurements you take for calculations save to the patient report You can display redo and delete saved measurements from a calculation For exam type availability see Imaging modes and exams available by transducer on page 21 WARNING To ensure high quality images all patient images must be obtained by qualified and trained individuals To avoid patient injury IMT results should not be used as a sole diagnostic tool All IMT results should be interpreted in conjunction with other clinical information or risk factors To avoid measurement errors all measurements must be of the common carotid artery CCA This tool is not intended for measuring the bulb or the internal carotid artery ICA To
19. probe See transducer R report patient 26 S safety battery 38 clinical 39 electrical 36 electromagnetic compatibility 40 equipment 38 save images 19 scanhead See transducer screen brightness 18 screen layout 5 security 9 setup pages 9 shipping specifications 71 SiteLink 13 skin line definition 74 sleep delay 12 software license 27 SonoHD technology 74 SonoMB technology 15 74 standards airborne equipment 72 electromechanical 72 EMC classification 72 HIPAA 72 storage alerts 13 storage specifications equipment 71 images 71 superficial intended uses 8 symbols labeling 64 system clean and disinfect 28 software 1 wake up 3 T Technical Support vii temperature limits 71 text 6 17 thermal index TI 13 48 74 time setup 13 Tissue Harmonic Imaging 22 tissue models 51 touchscreen clean 29 transducer clean and disinfect 29 connect 3 curved array 73 definition 74 disinfect 29 exam type 22 general use 6 imaging modes 22 invasive or surgical use 7 linear array 73 preparation 6 problems 27 sheath 7 troubleshoot 27 U ultrasound terminology 73 USB export 13 21 insert or remove device 4 user accounts 10 user guide conventions used vii user setup 10 Index 79 xopu uses intended 7 V vascular intended uses 8 WwW warnings definition vii Z zoom 16 80 Index BSonoSite P12529 01 AU AM
20. recommended for clinical applications of an invasive or surgical nature Do not apply the transducer sheath and gel until you are ready to perform the procedure Cleaning and disinfecting For a list of recommended disinfectants see the SonoSite Web site at www sonosite com Click Resources and then Documentation Cleaning and disinfecting the ultrasound system The exterior surface of the ultrasound system and the accessories can be cleaned and disinfected using a recommended cleaner or disinfectant WARNING To avoid electrical shock before cleaning disconnect the system from the power supply or remove it from the stand To avoid infection always use protective eyewear and gloves when performing cleaning and disinfecting procedures Caution Do not spray cleaners or disinfectant directly on the system surfaces Doing so may cause solution to leak into the system damaging the system and voiding the warranty Do not use strong solvents such as thinner or benzene or abrasive cleansers since these will damage the exterior surfaces Use only recommended cleaners or disinfectants on system surfaces Immersion type disinfectants are not approved for use on system surfaces When you clean the system ensure that the solution does not get inside the system controls or the battery compartment Do not scratch the touchscreen To clean the touchscreen K2 ye Dampen a clean non abrasive cot
21. the active aperture measured in cm P 3 Derated peak rarefactional pressure associated with the transmit pattern giving rise to the value reported under MI Megapascals Wo Ultrasonic power except for TIS 3 in which case it is the ultrasonic power passing through a one centimeter window in units of milliwatts W 3 z1 Derated ultrasonic power at axial distance z4 in units of milliwatts Ispta 3 Z1 Derated spatial peak temporal average intensity at axial distance z milliwatts per square centimeter Z1 Axial distance corresponding to the location of maximum min W 3 z lta 3 z x 1 cm where z gt zbp in centimeters Zbp 1 69 Aaprt in centimeters Chapter 6 Safety 61 Ayayes 62 Table 18 Acoustic Output Terms and Definitions Continued Term Definition Zsp For MI the axial distance at which p is measured For TIB the axial distance at which TIB is a global maximum for example z Zp 3 in centimeters deq z Equivalent beam diameter as a function of axial distance z and is equal to A 4 x Wo ITA z where lz z is the temporal average intensity as a function of z in centimeters fc Center frequency in MHz Dim of Aaprt Active aperture dimensions for the azimuthal x and elevational y planes in centimeters PD Pulse duration microseconds associated with the transmit pattern giving rise to the reported value of MI PRF Pulse repetition frequency associated with the transmit pattern gi
22. zoom in on an image You can freeze or unfreeze the image or change the imaging mode at any time while zooming 1 Tap Ox A ROI box appears 2 Drag the ROI box where desired 3 Tap Ox again The image in the ROI box is magnified by 100 4 Optional If the image is frozen drag to pan the image up down left and right To exit zoom tap A again Turning guidelines on and off Guidelines are for needle guidance and are an optional feature This feature depends on the transducer and exam type For more information see SonoSite Bracket and Needle Guide User Guide To turn guidelines on or off Ona2D image tap aj Annotating images You can annotate live images as well as frozen images You cannot annotate a saved image You can place text a predefined label an arrow or a pictograph To set preferences see Annotations setup on page 12 To place text or a label 1 Tap Annotate and select Text or Label A green cursor appears 2 Dragthe cursor where desired For text you can also tap Home to move the cursor to the home position See also To reset the home position on page 17 3 Doone ofthe following Fortext tap Keyboard and type text See Entering text on page 6 e Fora label tap Label and then tap the desired label group A x x B x x or C x x Turn the knob to select the label The first number shows which label in the group is selected The second number is the number of labe
23. 3 KR528102 KR532359 NO326202 NO326814 NZ542968 RCD000897368 0001 SP0815793 SP0881492 Patents pending P12529 01 05 2009 Copyright 2009 by SonoSite Inc All rights reserved Contents Introduction CONVENON RUNE UU UNES vii Gustomier COMMENTS sssini ord epa bo ierik iiio SE cb ver ES vii Chapter 1 Getting Started FOIGA OUt LEG e 2 Installing or removing the battery ER 2 Using AC power and charging the battery m 3 Turning the system on or off eese tette 3 Connecting transducers ccccssscsseccseccsscssssccssecssccsseecseccssccenccesscesscesasesssecsueeeseeess 3 Inserting and removing USB storage devices sss 4 kiere 5 General INCELACKION t M 5 TOUCHSCIOGIN e 5 Mamm 6 Entering text c HHMN 6 Preparing transducers sasscsiscisccsncssscsussciavscsiacdevassvesusectavecsnssiavavscansssdnansscanscovttecdusaiansnest 6 Intended USES C 7 Chapter 2 System Setup Displaying the setup pages sssscssssecssesecssescssssccssescssscesssccesssecesscesssesessecesnseeenseees 9 Restoring default settings csccsssscssseccssscscsseccsssessssecssssecsssecssssesssnecssssecssueessssecesseeess 9 Administration setup sssessssssssssessssesssssssoseeesessssoeeeesusssssterenuusssotereesnsssottreesssssotersnsssset 9 Security ise 9 USSF S
24. 3 user accounts 10 export type 14 F focal zones optimize 15 freeze 16 G grace period 27 guidance documents related 49 Guide 17 guidelines 17 gynecology intended uses 7 H HIPAA standard 72 home position 17 humidity limits 71 l image quality poor 27 images delete 21 export to USB 21 review 20 save 19 imaging modes list of 71 transducer 22 import predefined label groups 12 user accounts 10 in situ definition 73 include private tags 14 infertility intended uses 7 78 Index intended uses 7 intensity derated 50 in situ 50 water value 50 interventional intended uses 7 K keyboard on line 6 USB6 knob 6 L labeling symbols 64 labels placing on images 17 language 13 LCD screen output 48 license key 27 login Administrator 9 user 10 M maintenance 28 measurements accuracy 23 69 delete 24 edit 24 errors 69 publications 69 terminology 69 mechanical index MI 48 73 mode data 5 13 needle guide 17 NTSC definition 73 O OB intended uses 7 optimize 15 orientation marker 5 output display 48 P PAL definition 73 password 10 11 patient header 5 13 patient information form 18 20 patient list 19 patient report about 26 general 26 pediatric intended uses 8 peripherals 71 pictographs place 17 power delay 12 precision acoustic measurement 63 preferences 13 presets 13 pressure limits 71 print 20 print control 2 printer problem 27 setup 12
25. 6 Safety 37 Ayayes Equipment safety To protect your ultrasound system transducer and accessories follow these precautions Caution Excessive bending or twisting of cables can cause a failure or intermittent operation Improper cleaning or disinfecting of any part of the system can cause permanent damage For cleaning and disinfecting instructions see Chapter 5 Troubleshooting and Maintenance Do not submerge the transducer connector in solution The cable is not liquid tight beyond the transducer connector cable interface Do not use solvents such as thinner or benzene or abrasive cleaners on any part of the system Remove the battery from the system if the system is not likely to be used for some time Do not spill liquid on the system Battery safety To prevent the battery from bursting igniting or emitting fumes and causing personal injury or equipment damage observe the following precautions WARNING 38 The battery has a safety device Do not disassemble or alter the battery Charge the batteries only when the ambient temperature is between 0 and 40 C 32 and 104 F Do not short circuit the battery by directly connecting the positive and negative terminals with metal objects Do not heat the battery or discard it in a fire Do not expose the battery to temperatures over 60 C 140 F Keep it away from fire and other heat sources Do not charge the battery near a heat sou
26. Accessories and Peripherals Recommended by SonoSite Chapter 6 Safety 67 Ayayes 68 Chapter 7 References Measurement accuracy The measurements provided by the system do not define a specific physiological or anatomical parameter Rather the measurements are of a physical property such as distance for evaluation by the clinician The accuracy values require that you can place the calipers over one pixel The values do not include acoustic anomalies of the body The 2D linear distance measurement results are displayed in centimeters with one place past the decimal point if the measurement is ten or greater two places past the decimal point if the measurement is less than ten The linear distance measurement components have the accuracy and range shown in the following table 2D Measurement Accuracy and Range 2 OO 9 v gt o Fe 8 5 E ag 26 2 9 9 3 5 ge o 2 ag U pr G o x v 6 7 Er U cc Axial Distance lt 2 plus Acquisition Phantom 0 26cm 1 of full scale Lateral lt 2 plus Acquisition Phantom 0 35 cm Distance 1 of full scale Diagonal lt 2 plus Acquisition Phantom 0 44cm Distance 1 of full scale a Full scale for distance is defined as the maximum depth of the image displayed b An RMI413a model phantom with 0 7 dB cm MHz attenuation was used Sources of measurement errors In general two types of errors can be introduced into the measurement Acquis
27. B storage device that contains the accounts Log in as Administrator Tap Import Uu F amp F U N Tap Restart in the dialog box that appears The system restarts All user names and passwords on the system are replaced with the imported data Exporting and clearing the Event log The Event log collects errors and events and can be exported to a USB storage device and read on a PC To display the Event log 1 Log in as Administrator 2 Tap Log The Event log appears To return to the previous screen tap Back To export the Event log The Event log has the file name log txt Exporting the Event log to a USB storage device overwrites any existing log txt file 1 Insert a USB storage device 2 Tap Log and then tap Export A list of USB devices appears Select the USB storage device and tap Import 3 Select the USB storage device and tap Export The Event log is a text file that you can open ina text editing application for example Microsoft Word or Notepad To clear the Event log 1 Display the Event log 2 Tap Clear 3 Tap Yes Logging in as user If user login is required the User Login screen appears when you turn on the system See To require user login on page 10 To log in as user 1 Turn on the system 2 Inthe User Login screen type your name and password and tap OK To log in as guest Guests can scan but can t access system setup and patient information 1 Turn on the syst
28. CSA 601 1 1B 90 2002 CEI IEC 61157 2007 International Electrotechnical Commission Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment 72 Electrical UL 60601 1 1st Edition Underwriters Laboratories Medical Electrical Equipment Part 1 General Requirements for Safety EMC standards classification EN 60601 1 2 2007 European Norm Medical Electrical Equipment General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests CISPR11 2004 International Electrotechnical Commission International Special Committee on Radio Interference Industrial Scientific and Medical ISM Radio Frequency Equipment Electromagnetic Disturbance Characteristics Limits and Methods of Measurement The Classification for the ultrasound system stand accessories and peripherals when configured together is Group 1 Class A Airborne equipment standards RTCA DO 160E 2004 Radio Technical Commission for Aeronautics Environmental Conditions and Test Procedures for Airborne Equipment Section 21 0 Emission of Radio Frequency Energy Category B HIPAA standard The Health Insurance and Portability and Accountability Act Pub L No 104 191 1996 45 CFR 160 General Administrative Requirements 45 CFR 164 Security and Privacy Glossary Terms For ultrasound terms not included in this glossary refer to Recommended Ultrasound Terminol
29. I WD UU A W N Dock connector See the table Connectivity symbols on dock Chapter 1 Getting Started peus 6unyo5 Preparing the system Compartments and connectors The back of the system has a battery compartment a transducer compartment and a connector for the NanoMaxx dock The side has two USB ports See Figure 1 on page 1 Dock The dock has ports for the power supply printer cable and more It attaches to the back of the system See Figure 1 on page 1 Each port has a symbol that describes its use Connectivity symbols on dock Symbol Definition I DC input c Audio out B Print control G gt Composite video out PTa Composite video in To connect the dock WARNING To avoid electrical shock to the patient do not simultaneously touch the patient and the dock if it is disconnected from the system and connected to AC power Insert the dock into its connector on the back of the system See Figure 1 on page 1 The top of the dock has the SonoSite logo 2 About the system Fold out leg The fold out leg lets you set the system upright on a flat surface You can extend the leg as needed for your optimal viewing angle Figure 2 Back of system with fold out leg extended Installing or removing the battery WARNING To avoid injury to the operator and to prevent damage to the ultrasound system inspect the battery for leaks prior to installing To avoid data loss and to c
30. KV 4 0KV 8 0KV air 2KV on the mains 1KV on signal lines 0 5KV 1 0KV 2 0KV on AC power lines to ground 0 5KV 1 0KV on AC power lines to lines 2596 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Uz 30 dip in Ur for 25 cycles gt 5 Ur gt 95 dip in U7 for 5s Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the SonoSite ultrasound system requires continued operation during power mains interruptions it is recommended that the SonoSite ultrasound system be powered from an uninterruptible power supply ora battery Table 2 Manufacturer s Declaration Electromagnetic Immunity Continued Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Power Frequency Magnetic Field IEC 61000 4 8 Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 A m 3 Vrms 150 kHz to 80 MHz 3 Vim 80 MHz to 2 5 GHz 3 A m 3 Vrms 3 V m If image distortion occurs it may be necessary to position the SonoSite ultrasound system further from sources of power freq
31. LID e 10 Exporting or importing user accounts eesseecsessecesecsecssecseestecseecseeneessess 10 Exporting and clearing the Event log sees 11 Logging in as USer eese eeseen tentes ttn ttn ttontto tonta stnntta tones tton tnn 11 Choosing a secure password sees teentennt tnn ttnnttnn tnnt 11 Annotations SETUP eeeessescsecssecsecssecsecssccscccsecsecsccssceusensecuecssecsecseesseeaseeuecaserseesseeneesees 12 Audio Battery setup 12 Connectivity setup 12 Date and Time setup 13 Display Information setup 13 Presets setup 13 System Information Setup csssecssscsssssssecsscssseccseccssccsscssssecseecssccsssesseessecssnccenseesseess 13 USB DEVICES SOTU PD seisssscsssdescoscsenesssbessssizasesstcasessaayscuasetscesatetiensyeuseastosicaidaseaussestountetience 13 Limitations Of JPEG format eene ttti nennen tentes 14 Chapter 3 Imaging Imaging modes o eeessssesecssescrsssscessscccnsscesssccsnscecssscssuscesssecssssecsnsscssueesssscssnseseassensnsessss 15 2D imaging iustitie me Ez CPD and color Doppler imaging wel Adjusting depth and gain ou sssscssescssesecssescssesecnseecssesesssesessceesusecesseceensesesneeesneees 16 Freezing viewing frames and ZOOMING sees 16 Turning guidelines on and off e ieeserteeennnntttnnnnas 17 Annotatirg IMAGES eisses esie
32. Label MI Non scan TIC Scan Non scan AaprtS1 Aaprt gt 1 Global Maximum Index Value 1 1 a b pr3 MPa 1 95 Wo mW min of W 3 zi lr 3 Z1 Jl mW a E Z cm v 2 Zpp cm f 5 Zsp cm 5 1 8 deg Zsp cm i fc MH2 2 86 E _ Dim of Aaprt X cm Y cm PD usec 0 58 S PRF Hz 1249 E P Pll max MPa 3 22 S deq Pllmax cm Focal Length FL cm Z oO L 8 FLy cm lIpa 3 Mlmax W cm 226 0 Control 1 Mode CPD or Fal Color g n Control 2 Exam Type Abd Gyn VE Nrv OB 2 c Control 3 2D Optimization Pen O Control 4 Depth 7 8 cm amp Control 5 THI On Control 6 Color Box Default a This index is not required for this operating mode value is lt 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition since the global maximum index value is not reported for the reason listed Reference Global Maximum Index Value line 56 Table 14 Transducer Model L38n 10 5 Operating Mode 2D TIS TIB Index Label MI Non scan TIC Scan Non scan AaprtS1 Aaprt gt 1 Global Maximum Index Value 1 5 a b Pr3 MPa 3 23 Wo mW E min of W 5 z Ja 320 mW 5 Zz cm dE 1 cm z Zbp cm 5 Zsp cm 0 9 o deqZsp cm E fc MHz
33. NanoMaxx Ultrasound System User Guide CE EA SonoSite NanoMaxx Ultrasound System User Guide SonoSite Inc 21919 30th Drive SE Bothell WA 98021 USA T 1 888 482 9449 or 1 425 951 1200 F 1 425 951 1201 SonoSite Ltd Alexander House 40A Wilbury Way Hitchin Herts SG4 0AP UK T 44 1462 444800 F 44 1462 444801 Caution Federal United States law restricts this device to sale by or on the order of a physician NanoMaxx SiteLink SonoSite and the SonoSite logo are registered trademarks or trademarks of SonoSite Inc DICOM is the registered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information The SonoSite product s referenced in this document may be covered by one or more of the following U S patents 5722412 5817024 5893363 6135961 6203498 6364839 6371918 6383139 6416475 6447451 6471651 6569101 6648826 6575908 6604630 6817982 6835177 6962566 7169108 7449640 D456509 D461895 D509900 D538432 D544962 D558351 D559390 D591423 and by the following counterpart foreign patents AU727381 AU730822 CA2373065 CN ZL 97113678 5 CN ZL 98106133 8 CN ZL 98108973 9 DE60021552 0 DE60029777 2 DE60034670 6 DE69730563 5 DE6980539 6 DE6983 1698 3 FR0815793 FR0875203 FR0881492 FR1175713 FR1180970 GB0815793 GB0875203 GB0881492 GB1175713 GB1180970 GB1180971 IT0815793 IT0881492 IT117571
34. apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the SonoSite ultrasound system is used exceeds the applicable RF compliance level above the SonoSite ultrasound system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the SonoSite ultrasound system b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m ALARA principle ALARA is the guiding principle for the use of diagnostic ultrasound Sonographers and other qualified ultrasound users using good judgment and insight determine the exposure that is as low as reasonably achievable There are no set rules to determine the correct exposure for every situation The qualified ultrasound user determines the most appropriate way to keep exposure low and bioeffects to a minimum while obtaining a diagnostic examination A thorough knowledge of the imaging modes transducer ca
35. ations that might occur Of course every transducer system combination has its own unique characteristic acoustic output and will not match the nominal output on which the display estimates are based This variability between systems and transducers introduces an error into displayed value By doing acoustic output sampling testing during production the amount of error introduced by the variability is bounded The sampling testing ensures that the acoustic output of transducers and systems being manufactured stays within a specified range of the nominal acoustic output Another source of error arises from the assumptions and approximations that are made when deriving the estimates for the display indices Chief among these assumptions is that the acoustic output and thus the derived display indices are linearly related with the transmit drive voltage of the transducer Generally this assumption is very good but it is not exact and thus some error in the display can be attributed to the assumption of voltage linearity Related guidance documents Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers FDA 2008 Medical Ultrasound Safety American Institute of Ultrasound in Medicine AIUM 2008 A copy is included with each system Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment NEMA UD2 2004 Standard for Real Time Display of Thermal and Mechanical Aco
36. avoid incorrect calculations verify that the patient information date and time settings are accurate To avoid misdiagnosis or harming the patient outcome start a new patient information form before starting a new patient exam and performing calculations Starting a new patient information form clears the previous patient s data The previous patient s data will be combined with the current patient if the form is not first cleared See To create a new patient information form on page 18 To perform an IMT measurement Repeat this procedure for each IMT measurement you want to take 1 2 On a frozen 2D image tap Calcs Tap Right or Left for the side measured The setting displayed is the side measured Tap IMT and select a measurement Measurements already performed have a check mark e Lat F Lateral Far Wall e Lat N Lateral Near Wall Post F Posterior Far Wall e Post N Posterior Near Wall e Ant F Anterior Far Wall e Ant N Anterior Near Wall The IMT tool appears Using the IMT tool controls position and adjust the tool as needed See IMT tool controls on page 25 If you want to save the measurement tap Save The measurement saves to the patient report and the image with the measurement displayed saves to internal storage Exit the measurement by tapping one of the following Unfreeze to return to live imaging Clear Calc to clear the measurement from the screen a
37. c output measurement 50 tables 54 terms in tables 61 acquisition error 69 add new user 10 Administrator 9 AE Title DICOM 14 airborne equipment standards 72 ALARA principle 44 45 73 alerts storage 13 annotations place 17 predefine label groups 12 arrow graphic 17 audio 2 12 battery charge 3 clean 31 install or remove 2 safety 38 setup 12 specifications 72 biological safety 39 Biopsy 17 brightness screen 18 C cables connect power 3 calculations about 24 IMT 24 calipers 23 cardiac intended uses 7 Carotid IMT 23 cautions definition vii CIMT 23 cine buffer 16 clean battery 31 system 28 touchscreen 29 transducers 29 color Doppler Color imaging 15 color power Doppler CPD imaging 15 Color See color Doppler Color imaging connectivity setup 12 control keys 5 controls direct 45 indirect 46 receiver 46 CPD See color power Doppler CPD imaging customer assistance vii D date setup 13 default settings 9 depth adjust 16 definition 73 marker 5 13 DICOM 13 disinfect battery 31 system 28 transducers 29 E electrical safety 36 electromagnetic compatibility 40 electromechanical safety standards 72 EMC classification standards 72 equipment safety 38 error message 37 errors acquisition 69 Index 77 xopu algorithmic 69 measurement 69 Event log 11 exam end 18 type and transducer 22 type change 21 export Event log 11 images 21 predefined label groups 12 USB Devices setup 1
38. cer connector and back of the display enclosure can reach temperatures that exceed EN 60601 1 limits for patient contact therefore only the operator shall handle the system This does not include the transducer face To avoid the risk of electrical shock or injury do not open the system enclosures All internal adjustments and replacements except battery replacement must be made by a qualified technician To avoid the risk of injury do not operate the system in the presence of flammable gasses or anesthetics Explosion can result To avoid the risk of electrical shock use only properly grounded equipment Shock hazards exist if the power supply is not properly grounded Grounding reliability can only be achieved when equipment is connected to a receptacle marked Hospital Only or Hospital Grade or the equivalent The grounding wire must not be removed or defeated To avoid the risk of electrical shock when using the system in an environment where the integrity of the protective earth conductor arrangement is in doubt operate the system on battery power only without using the power supply To avoid the risk of electrical shock do not connect the system s power supply or the V Universal Stand s auxiliary mains outlet receptacles to an MPSO or extension cord To avoid the risk of electrical shock before using the transducer inspect the transducer face housing and cable Do not use the transducer if the transducer or cable
39. cer for each exam type see Imaging modes and exams available by transducer on page 21 Abdominal Imaging Applications The liver kidneys pancreas spleen gallbladder bile ducts transplanted organs abdominal vessels and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally Cardiac Imaging Applications The heart cardiac valves great vessels surrounding anatomical structures overall cardiac performance and heart size can be assessed for the presence or absence of pathology Gynecology and Infertility Imaging Applications The uterus ovaries adnexa and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally Interventional Imaging Applications You can use the system to provide ultrasound guidance for biopsy and drainage procedures vascular line placement peripheral nerve blocks spinal nerve blocks and taps amniocentesis and other obstetrical procedures and to provide assistance during abdominal and breast surgery Obstetrical Imaging Applications The fetal anatomy amniotic fluid and surrounding anatomical structures can be assessed for the presence or absence of pathology transabdominally CPD and color Doppler Color imaging is intended for evaluating the presence or absence of flow Chapter 1 Getting Started 7 peus bunya WARNING To prevent injury or misdiagnosis do not use this system for Per
40. cutaneous Umbilical Blood Sampling PUBS or in vitro Fertilization IVF The system has not been validated to be proven effective for these two uses CPD or Color images can be used as an adjunctive method not as a screening tool for the following Detection of structural anomalies of the fetal heart Diagnosis of Intrauterine Growth Retardation IUGR Pediatric and Neonatal Imaging Applications The pediatric abdominal and pelvic anatomy pediatric hips and surrounding anatomical structures can be assessed for the presence or absence of pathology Superficial Imaging Applications The breast thyroid testicle lymph nodes hernias musculoskeletal structures soft tissue structures and surrounding anatomical structures can be assessed for the presence or absence of pathology The system can be used to provide ultrasound guidance for biopsy and drainage procedures vascular line placement peripheral nerve blocks and spinal nerve blocks and taps Vascular Imaging Applications The carotid arteries deep veins and arteries in the arms and legs superficial veins in the arms and legs great vessels in the abdomen and various small vessels can be assessed for the presence or absence of pathology 8 Intended uses Chapter 2 System Setup The setup pages let you customize the system and set preferences Displaying the setup pages To display a setup page 1 Tap More and select Setup 2 Do any of the following
41. d a new user 1 Login as Administrator 2 Tap New 10 Administration setup 3 Under User Information fill in the Name Password and Confirm boxes See Choosing a secure password on page 11 4 Optional In the User box type the user s initials to display them in the patient header and in the User box in the patient information form 5 Optional Select the Administration Access check box to allow access to all administration privileges 6 Tap Save To modify user information 1 Log in as Administrator 2 Under User List select the user 3 Under User Information make changes as desired 4 Tap Save Any change to the user name replaces the previous name To delete a user 1 Log in as Administrator 2 Under User List select the user 3 Tap Delete 4 Tap Yes to confirm deletion To change a user password 1 Log in as Administrator 2 Inthe User List tap the user 3 Type the new password in the Password box and Confirm box 4 Tap Save Exporting or importing user accounts The export and import commands let you configure multiple systems and back up user account information To export user accounts 1 Insert a USB storage device 2 Login as Administrator 3 Tap Export A list of USB devices appears 4 Select the USB storage device and tap Export All user names and passwords are copied to the USB storage device Passwords are encrypted To import user accounts 1 Insert the US
42. e label and tap Delete See also Entering text on page 6 To export predefined label groups 1 Insert a USB storage device 2 Onthe Annotations setup page tap Export A list of USB devices appears 3 Select the USB storage device and tap Export A copy of all predefined label groups for all exams saves to the USB storage device 12 Annotations setup To import predefined label groups 1 Insertthe USB storage device that contains the label groups 2 Onthe Annotations setup page tap Import 3 Select the USB storage device and then tap Import 4 Tap OK in the dialog box that appears All predefined label groups for all exams are replaced with those from the USB storage device Audio Battery setup On the Audio Battery setup page you can select options from the following lists Key click Select On or Off for controls to make a clicking sound when tapped Beep alert Select On or Off for the system to beep when saving warning starting or shutting down Sleep delay Select Off or 5 or 10 minutes to specify the period of inactivity before the system goes into sleep mode Power delay Select Off or 15 or 30 minutes to specify the period of inactivity before the system automatically turns off Connectivity setup On the Connectivity setup page you select options for using devices and for alerts when internal storage is full To configure the system for a printer 1 Set up the printer hardware
43. e tables see Terms used in the acoustic output tables on page 61 54 Table 12 Transducer Model C60n 5 2 Operating Mode 2D TIS TIB Index Label MI Non scan TIC Scan Non scan AaprtS1 Aaprt gt 1 Global Maximum Index Value 1 1 a b Pr3 MPa 1 95 Wo mW E min of W 3 z4 lza 3 z4 mW 3 5 Z cm lt 0 iz cm itk 2E So i S dez cm lt fe MHz 2 86 n E Dim of Aaprt X cm Y cm PD usec 0 58 S PRF Hz 4827 E P Pllmax MPa 3 22 S deg Pllmax cm Focal Length FL cm E EN amp FL cm n um lp 3 M max W cm 226 0 p Control 1 Exam Type OB z Control 2 2D Optimization Any z Control 3 Depth 7 8 cm amp 8 Control 4 THI On S 9 Control 5 MB Multi Beam Off O a This index is not required for this operating mode value is lt 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition since the global maximum index value is not reported for the reason listed Reference Global Maximum Index Value line Data are not applicable for this transducer mode Chapter 6 Safety 55 Ayayes Table 13 Transducer Model C60n 5 2 Operating Mode CPD Color TIS TIB Index
44. e the device To insert a USB storage device Insert the USB storage device into a USB port oe on the system See Figure 1 on page 1 The USB storage device is ready when the USB icon appears To view information about the device see USB Devices setup on page 13 To remove a USB storage device Removing the USB storage device while the system is exporting may cause the exported files to be corrupted or incomplete 1 Wait at least five seconds after the USB animation stops 2 Remove the USB storage device from the port Screen layout 1 2 3 4 5 Figure 4 Screen Layout 1 Text Text entered using on screen keyboard 2 Pictograph Indicates anatomy and transducer position You can select anatomy and screen location 3 Orientation marker Shows image orientation 4 Measurement 5 Mode data and system status Current imaging mode information such as Gen MB and system information such as exam type transducer and battery charging To specify details see System Information setup on page 13 6 Patient header Includes current patient name patient ID number institution user date and time 7 Depth marker Marks in 5 cm 1 cm and 5 cm increments depending on depth To specify style see Presets setup on page 13 8 Controls available in the current context See Touchscreen on page 5 9 Ultrasound image 10 Measurement data General interaction Touchscreen The touchscree
45. ecsssssascesscsssecsuceeseeeseeesseess 34 Position yo UE Self susce apetito de tes senvssasSuschdesvaust cbusetaaudhchavacassustesersbane 34 Take breaks exercise and vary activities sss 35 Electrical safety classification 2 35 Electrical safety 2 36 Equipment safety iscscctscstcetdeacceschecthcossscacetescdessceacasoscenschenchandicoacosteaducsdvibedshiacassiventecens 38 Battery tiia 38 Glinicalisafetyu et ettet bre sepe nte iai 39 Hazardous materials eese tentent tenentes nai 40 Electromagnetic compatibility eese teen teenntennnten 40 Manufacturer s declaration eese tente ttnttnttntn nnne 41 PUE nere Q 44 APPlying ALARA 45 Direct controls AS Indirect controls Receiver controls Acoustic artifacts 46 Guidelines for reducing MI and TI 46 O tput display cxsssssssveccesessscenusesdhastuscesesauestoxsssaseateescesarnsecisssosusaseastecqrbectactenachotensotennssets 48 MI and TI output display accuracy eene 48 Factors that contribute to display uncertainty ss 49 Related guidance documents sssesssecssecsssssssesssecsseesseecsecesasessteessccesseesseess 49 Transducer surface temperature rise cecsescsssecseeccseecseecsssecssecssecsscesseecsecesseesses 50 Acoustic output measurement sescesec
46. ee SonoSite Technical Support on page vii System does not turn on Check all power connections Remove the DC input connector and battery wait 10 seconds reinstall the battery and then reinstall the DC input connector Ensure that the battery is charged System image quality is poor Adjust the screen to improve viewing angle Adjust the brightness Adjust the gain No CPD image Adjust the gain No Color image Adjust the gain or the scale Print does not work Select the printer on the Connectivity setup page See To configure the system for a printer on page 12 Check the printer connections Ensure that the printer is turned on and set up properly See the printer manufacturer s instructions if necessary Missing control Tap Page x x to display additional controls System does not recognize the transducer Disconnect and reconnect the transducer Make sure that the connectors are free of debris Verify that you are using a supported transducer A maintenance icon appears System maintenance may be required Record the number in parentheses on the C line and contact SonoSite or your SonoSite representative Software licensing SonoSite software is controlled by a license key After you install new software the system prompts you for a license key You must obtain one key for the system and one key for the transducer The software will operate for a short time the grace period without a
47. ee last reference in Related guidance documents below Table 5 indicates for each transducer and operating mode if either the TI or MI is greater than or equal to a value of 1 0 thus requiring display Table 5 Tl or Ml is gt 1 0 Transducer Model Index 2D ind C11n 8 5 MI No No TIC TIB or TIS No No C60n 5 2 MI Yes Yes TIC TIB or TIS No No L25n 13 6 MI No No TIC TIB or TIS No No L38n 10 5 MI Yes Yes TIC TIB or TIS No Yes P21n 5 1 MI Yes Yes TIC TIB or TIS No Yes Even when Ml is less than 1 0 the system provides a continuous real time display of MI in all imaging modes in increments of 0 1 The system meets the output display standard for TI and provides a continuous real time display of TI in all imaging modes in increments of 0 1 The TI consists of three user selectable indices and only one of these is displayed at any one time In order to display TI properly and meet the ALARA principle the user selects an appropriate TI based on the specific exam being performed SonoSite provides a copy of AIUM Medical Ultrasound Safety which contains guidance on determining which TI is appropriate See Related guidance documents on page 49 MI and TI output display accuracy 48 The accuracy result for the MI is stated statistically With 95 confidence 95 of the measured MI values will be within 18 to 25 of the displayed MI value or 0 2 of the displayed value whichever value is larger The accuracy res
48. em 2 Inthe User Login screen select Guest To change your password 1 Turnon the system 2 Inthe User Login screen tap Password 3 Type your old and new passwords confirm the new password and then tap OK Choosing a secure password To ensure security choose a password that contains uppercase characters A Z lowercase characters a z and numbers 0 9 Passwords are case sensitive Chapter 2 System Setup 11 dnjas Annotations setup On the Annotations setup page you can customize predefined labels and set the preference for managing text when unfreezing images For instructions to annotate images see Annotating images on page 17 To predefine a label group You can specify which labels are available for an exam type when annotating an image See To place text or a label on page 17 1 Inthe Exam list on the Annotations setup page select the exam type whose labels you want to specify 2 For Group select A B or C for the label group you want associated with that exam The preset labels for the selected group appear in the scroll list 3 Doany ofthe following Add a custom label to the group Select New from the list type the label in the Text box and tap Add Rename a label Select the label type the new name in the Text box and tap Rename Move a label within the group Select the label and then tap the up or down arrow Delete a label from a group Select th
49. ending on your archiver the two exams appear as one study when exported 1 Select the patient exam in the patient list 2 Tap Append A new patient information form appears The form has the same information as the patient exam you selected To review images from the patient list You can review only one patient exam s images at a time 1 Inthe patient list tap the patient exam whose images you want to review The row is highlighted 2 Tap Review Two numbers x x appear the file displayed and the total files saved 3 Turn the knob or tap the arrows lt gt to cycle through images To return to the patient list tap List To return to imaging tap Done 20 Images To review images for the current patient 1 Tap More and select Review Two numbers x x appear the file displayed and the total files saved 2 Turn the knob or tap the arrows lt gt to cycle through images To display the patient list tap List To return to imaging tap Done Printing exporting and deleting images WARNING To avoid damaging the USB storage device and losing patient data from it observe the following Do not remove the USB storage device or turn off the ultrasound system while the system is exporting Do not bump or otherwise apply pressure to the USB storage device while it is in a USB port on the ultrasound system The connector could break To print an image 1 Verify that a printer is selected
50. er e 0 0995 Since this value is not the true In Situ intensity the term derated is used to qualify it The maximum derated and the maximum water values do not always occur at the same operating conditions therefore the reported maximum water and derated values may not be related by the In Situ derated formula For example a multi zone array transducer that has maximum water value intensities in its deepest zone but also has the smallest derating factor in that zone The same transducer may have its largest derated intensity in one of its shallowest focal zones Tissue models and equipment survey Tissue models are necessary to estimate attenuation and acoustic exposure levels In Situ from measurements of acoustic output made in water Currently available models may be limited in their accuracy because of varying tissue paths during diagnostic ultrasound exposures and uncertainties in the acoustic properties of soft tissues No single tissue model is adequate for predicting exposures in all situations from measurements made in water and continued improvement and verification of these models is necessary for making exposure assessments for specific exam types A homogeneous tissue model with attenuation coefficient of 0 3 dB cm MHz throughout the beam path is commonly used when estimating exposure levels The model is conservative in that it overestimates the In Situ acoustic exposure when the path between the transducer and site of intere
51. evice If you want to hide patient information deselect Include patient information on images Only available USB devices are selectable 5 Tap Export The files are finished exporting approximately five seconds after the USB animation stops Removing the USB storage device or turning off the system while exporting may cause exported files to be corrupted or incomplete To stop in progress exporting tap Cancel Export To delete images 1 Selectoneor more patient exams in the patient list 2 Tap Delete to delete the selected exams A confirmation screen appears Imaging modes and exams available by transducer WARNING To prevent misdiagnosis or harm to the patient understand your system s capabilities prior to use The diagnostic capability differs for each transducer exam type and imaging mode In addition transducers have been developed to specific criteria depending on their physical application These criteria include biocompatability requirements The transducer you use determines which exam types are available In addition the exam type you select determines which imaging modes are available To change the exam type Do one of the following e In2D imaging tap Exam and select the exam type Onthe patient information form select the exam type in the Type list under Exam See Patient information form on page 18 Chapter 3 Imaging 21 Imaging modes and exams available Imaging mode
52. f you use images in SonoCalc IMT software you should transfer or export them using BMP format SonoCalc IMT software uses a sophisticated algorithm to measure images and lossy compression may cause errors For more information on using lossy compressed images consult the industry literature including the following references Physics in Medicine and Biology Quality Assessment of DSA Ultrasound and CT Digital Images Compressed with the JPEG Protocol D Okkalides et al 1994 Phys Med Biol39 1407 1421 doi 10 1088 0031 9155 39 9 008 www iop org EJ abstract 0031 9155 39 9 008 Canadian Association of Radiologists CAR Standards for Irreversible Compression in Digital Diagnostic Imaging within Radiology Approved June 2008 www car ca Files 5CLossy_Compression pdf Chapter 3 Imaging Imaging modes 2D controls Imaging modes available depend on the The current optimization setting transducer and exam type See Imaging modes appears below the icon and exams available by transducer on page 21 Res provides the best resolution Gen provides a balance between 2D imaging resolution and penetration 2D is the system s default imaging mode The Pen provides the best penetration system displays echoes in two dimensions by Some of the parameters optimized to assigning a brightness level based on the echo provide the best image include focal signal amplitude To achieve the best image zones aperture size frequenc
53. fessional to determine stretches and exercises that are right for you Electrical safety classification Class equipment Internally powered equipment Type BF applied parts IPX 7 watertight equipment Non AP APG The ultrasound system is classified as Class equipment when powered from the power supply or V Universal Stand because of the Class 1 protectively earthed power supply The system itself has no protective earth and is Class Il The stand has no protective earth Ground bond testing is not applicable Ultrasound system not connected to the power supply battery only Ultrasound transducers Ultrasound transducers Ultrasound system power supply V Universal Stand and peripherals Equipment is not suitable for use in the presence of flammable anaesthetics Chapter 6 Safety 35 Ayayes Electrical safety 36 This system meets EN 60601 1 Class I internally powered equipment requirements and Type BF isolated patient applied parts safety requirements This system complies with the applicable medical equipment requirements published in the Canadian Standards Association CSA European Norm Harmonized Standards and Underwriters Laboratories UL safety standards See Chapter 8 Specifications For maximum safety observe the following warnings and cautions WARNING To avoid discomfort or minor risk of patient injury keep hot surfaces away from the patient Under certain circumstances the transdu
54. hazard do not use the transducer with high frequency surgical equipment Such a hazard may occur in the event of a defect in the high frequency surgical neutral electrode connection Do not use the system if it exhibits erratic or inconsistent behavior Discontinuities in the scanning sequence are indicative of a hardware failure that must be corrected before use Perform ultrasound procedures prudently Use the ALARA as low as reasonably achievable principle and follow the prudent use information concerning MI and TI SonoSite does not currently recommend a specific brand of acoustic standoff If an acoustic standoff is used it must have a minimum attentuation of 3dB cm MHz Some SonoSite transducers are approved for intraoperative applications if a market cleared sheath is used Chapter 6 Safety 39 Ayayes Hazardous materials WARNING The liquid crystal display LCD contains mercury Dispose of the LCD properly in accordance with local regulations Electromagnetic compatibility The ultrasound system has been tested and found to comply with the electromagnetic compatibility EMC limits for medical devices to IEC 60601 1 2 2007 These limits are designed to provide reasonable protection against harmful interference in a typical medical installation Caution 40 Medical electrical equipment requires special precautions regarding EMC and must be installed and operated according to these instructions It is possible
55. ing Symbols Symbol Definition NY CC CC 0086 A LOT amp Ax INMETRO OCP 0004 e REF x o a STERILE EO Alternating Current AC Class 1 device indicating manufacturer s declaration of conformance with Annex VII of 93 42 EEC Class 1 device requiring verification by the Notified Body of sterilization or measurement features or to a Class lla IIb or IIl device requiring verification or auditing by the Notified Body to applicable Annex es of 93 42 EEC Attention see the user guide Device complies with relevant Australian regulations for electronic devices Batch code date code or lot code type of control number Biological risk Device complies with relevant Brazilian regulations for electro medical devices Canadian Standards Association The C and US indicators next to this mark signify that the product has been evaluated to the applicable CSA and ANSI UL Standards for use in Canada and the US respectively Catalog number Collect separately from other household waste see European Commission Directive 93 86 EEC Refer to local regulations for disposal Contents sterilized using ethylene oxide process Table 20 Labeling Symbols Continued Symbol Definition G Corrugated recycle Corrugated Recycles P 4 e OU 00 D 2 4 ay GEL STERILE Dangerous voltage Da
56. is damaged To avoid the risk of electrical shock always disconnect the power supply from the system before cleaning the system After cleaning verify that the system is dry before reconnection and use To avoid the risk of electrical shock do not use any transducer that has been immersed beyond the specified cleaning or disinfection level See Chapter 5 Troubleshooting and Maintenance WARNING Caution To avoid the risk of electrical shock to the patient do not simultaneously touch the patient and the ungrounded signal input output connectors on the back of the ultrasound system To avoid the risk of electrical shock and fire hazard inspect the power supply AC power cord and plug on a regular basis Ensure that they are not damaged To avoid the risk of electrical shock and fire hazard the power cord set that connects the power supply of the ultrasound system or V Universal Stand to mains power must only be used with the power supply or V Universal Stand and cannot be used to connect other devices to mains power To avoid the risk of electrical shock use only accessories and peripherals recommended by SonoSite including the power supply Connection of accessories and peripherals not recommended by SonoSite could result in electrical shock Contact SonoSite or your local representative for a list of accessories and peripherals available from or recommended by SonoSite To avoid the risk of electrical shock inspec
57. ition Error Includes errors introduced by the ultrasound system electronics relating to signal acquisition signal conversion and signal processing for display Additionally computational and display errors are introduced by the generation of the pixel scale factor application of that factor to the caliper positions on the screen and the measurement display Algorithmic Error The error introduced by measurements which are input to higher order calculations This error is associated with floating point versus integer type math which is subject to errors introduced by rounding versus truncating results for display of a given level of significant digit in the calculation Measurement publications IMT The following publications are used for each IMT calculation result Terminology and measurements comply with AIUM published standards Howard G Sharrett AR Heiss G Evans GW Chambless LE Riley WA et al Carotid Artery Intima Medial Thickness Distribution in General Populations As Evaluated by B Mode Ultrasound ARIC Investigators Atherosclerosis Risk in Communities Stroke 1993 24 1297 1304 O Leary Daniel H MD and Polak Joseph F MD et al Use of Sonography to Evaluate Carotid Atherosclerosis in the Elderly The Chapter 7 References 69 so uaJoJay 70 Cardiovascular Health Study Stroke September 1991 22 1155 1163 Redberg Rita F MD and Vogel Robert A MD et al Task force 3
58. l C60n 5 2 Global Maximum Output Levels max Ispta 3 min Ispta 3 max MI min MI max TIS min TIS max TIB min TIB max TIC min TIC Mode of Operation 2D Color CPD 30 89 24 71 1 16 1 20 1 06 1 08 0 34 0 61 0 28 0 49 0 34 0 61 0 28 0 49 1 21 1 42 0 97 1 14 Table 9 Transducer Model L25n 13 6 Global Maximum Mode of Operation Output Levels 2D Color CPD max IsPTA 3 72 173 min IcPTA 3 56 107 max MI 0 82 0 92 min MI 0 72 0 74 max TIS 0 43 1 04 min TIS 0 33 0 64 max TIB 0 43 1 04 min TIB 0 33 0 64 max TIC 0 83 1 40 min TIC 0 64 0 86 Chapter 6 Safety 53 Ayayes Table 10 Transducer Model L38n 10 5 Global Maximum Mode of Operation Output Levels 2D Color CPD max IsPTA 3 169 258 min IsPTA 3 141 216 max MI 1 65 1 54 min MI 1 54 1 36 max TIS 0 90 1 24 min TIS 0 76 1 04 max TIB 0 90 1 24 min TIB 0 76 1 04 max TIC 2 46 2 42 min TIC 2 24 2 02 Table 11 Transducer Model P21n 5 1 Global Maximum Mode of Operation Output Levels 2D Color CPD maXlpja3 54 10 min lspTA 3 44 128 max MI 1 46 1 70 min MI 1 40 1 52 max TIS 1 00 1 44 min TIS 0 82 1 32 max TIB 1 00 1 44 min TIB 0 82 1 32 max TIC 2 44 2 43 min TIC 1 98 2 23 Acoustic output tables The following tables indicate the acoustic output for the system and transducer combinations with a TI or MI equal to or greater than one These tables are organized by transducer model and imaging mode For a definition of terms used in th
59. l Hazard Journal of Diagnostic Medical Sonography 3 1985 121 125 C Smith C S G W Wolf G Y Xie and M D Smith Musculoskeletal Pain in Cardiac Ultrasonographers Results of a Random Survey Journal of American Society of Echocardiography May1997 357 362 d Wihlidal L M and S Kumar An Injury Profile of Practicing Diagnostic Medical Sonographers in Alberta International Journal of Industrial Ergonomics 19 1997 205 216 e Habes DJ and S Baron Health Hazard Report 99 0093 2749 University of Medicine and Dentistry of New Jersey 1999 Chapter 6 Safety 33 Ayayes f Vanderpool H E E A Friis B S Smith and K L Harms Prevalence of Carpal Tunnel Syndrome and Other Work related Musculoskeletal Problems in Cardiac Sonographers Journal of Medicine 35 6 1993 605 610 Position the system Promote comfortable shoulder arm and hand postures Use a stand to support the weight of the ultrasound system Minimize eye and neck strain If possible position the system within reach Adjust the angle of the system and display to minimize glare e If using a stand adjust its height so that the display is at or slightly below eye level Position yourself 34 Support your back during an exam Usea chair that supports your lower back that adjusts to your work surface height that promotes a natural body posture and that allows for quick height adjustments Sitor stand upright Avoid
60. llowing additional measurements on the image IMT tool controls The IMT tool has the following controls Left Right Repositions the tool horizontally or vertically With Left Right turn the knob clockwise to move the tool right or counter clockwise to move the tool left With Up Down turn the knob clockwise to move the tool down or counter clockwise to move Up Down the tool up A Adjusts the lumen intima line Turn Y the knob clockwise to move the line Lumen down or counter clockwise to move the line up A Adjusts the adventitia media line Turn the knob clockwise to move Adventitia the line down or counter clockwise to move the line up Hide Use to check results Tap to hide the Show measurement results and trace line Tap again to redisplay them 4 gt Adjusts the tool width Turn the knob clockwise to increase the Width width or counter clockwise to decrease it Smooth Adjusts the IMT line smoothing When Smooth is set to On s appears after the measurement result at the bottom of the screen To measure plaque 1 2 3 On a frozen 2D image tap Calcs Tap Right Left for the side measured Tap Plaque and select Plaq 1 or Plaq 2 A set of calipers appears Position the calipers as desired See Working with calipers on page 23 Chapter 4 Measurements and Calculations 25 s uUsWaiNseay 5 If you want to save the measurement tap Save The measurement saves to the patient report
61. ls available See Annotations setup on page 12 To return to the previous screen tap Back To reset the home position The home position is where the cursor initially appears 1 Tap Annotate and select Text A green cursor appears 2 Drag the cursor where desired 3 Tap Home Set To return to the previous screen tap Back To place an arrow You can add an arrow graphic to point out a specific part of the image 1 Tap Annotate and select Arrow 2 Adjustthe arrow s orientation as needed Tap Rotate Arrow and then turn the knob 3 Dragthe arrow where desired To remove the arrow tap Hide Tap Show to display it again To return to the previous screen tap Back To place a pictograph The pictograph set available depends on transducer and exam type 1 Tap Annotate and select Picto 2 Turn the knob to display the desired pictograph The first number shows which pictograph in the set is selected The second number is the number of pictographs available 3 Drag the pictograph marker where desired 4 Rotate the pictograph marker as needed Tap Rotate Marker and then turn the knob Chapter 3 Imaging 17 5 Tap Position for a screen location for the pictograph U L Up Left D L Down Left D R Down Right or U R Up Right To remove the pictograph tap Hide Tap Show to display it again To return to the previous screen tap Back Adjusting screen brightness The screen brightness affect
62. measured and calculated in accordance with Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment NEMA UD2 2004 and Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment NEMA UD3 2004 In Situ derated and water value intensities 50 All intensity parameters are measured in water Since water does not absorb acoustic energy these water measurements represent a worst case value Biological tissue does absorb acoustic energy The true value of the intensity at any point depends on the amount type of tissue and the frequency of the ultrasound passing through the tissue The intensity value in the tissue In Situ has been estimated by using the following formula In Situ Water e2349 where In Situ In Situ intensity value Water Water intensity value e 2 7183 a attenuation factor dB cm MHz Attenuation factor a for various tissue types brain 0 53 heart 0 66 kidney 0 79 liver 0 43 muscle 0 55 l skinline to measurement depth in cm f center frequency of the transducer system mode combination in MHz Since the ultrasonic path during the exam is likely to pass through varying lengths and types of tissue it is difficult to estimate the true In Situ intensity An attenuation factor of 0 3 is used for general reporting purposes therefore the In Situ value commonly reported uses the formula In Situ derated Wat
63. midity limits Operating System battery and transducer 10 40 C 50 104 F 15 95 R H 700 to 1060hPa 0 7 to 1 05 ATM Shipping and storage System and transducer 35 65 C 31 149 F 15 95 R H 500 to 1060hPa 0 5 to 1 05 ATM Battery 20 60 C 4 140 F 15 95 R H For storage longer than 30 days store at or below room temperature 500 to 1060hPa 0 5 to 1 05 ATM Chapter 8 Specifications 71 suone yioedg Electrical Power Supply Input 100 240 VAC 50 60 Hz 2 0 A Max 100 VAC Power Supply Output 1 15 VDC 5 0 A Max Power Supply Output 2 12 VDC 2 3 A Max Battery The battery comprises six lithium ion cells plus electronics a temperature sensor and battery contacts Run time is at least 45 minutes depending on imaging mode and display brightness Electromechanical safety standards EN 60601 1 2003 European Norm Medical Electrical Equipment Part 1 General Requirements for Safety EN 60601 1 1 2001 European Norm Medical Electrical Equipment Part 1 General Requirements for Safety Section 1 1 Collateral Standard Safety Requirements for Medical Electrical Systems EN 60601 2 37 2008 European Norm Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment CAN CSA C222 No 601 1 M90 2002 Canadian Standards Association Medical Electrical Equipment Part 1 General Requirements for Safety including CSA 601 1 Supplement 1 1994 and
64. n has controls that change dynamically depending on context For example freezing an image displays the controls for zooming performing measurements and reviewing the cine buffer To select a control tap it with your finger or a stylus A control functions in one of the following ways Cycles through a list of settings Identified by a plus sign Displays a list from which to select Identified by an arrow amp Tapping the control displays and collapses the list Works in conjunction with the knob Identified by a double circle 9 e Turns a feature on or off Performs an action such as saving an image The Page x x control displays additional controls You can also reposition some elements for example the zoom box or calipers by dragging with your finger or stylus Chapter 1 Getting Started 5 peus bunya Knob The knob works in conjunction with some touchscreen controls and adjusts gain depth brightness annotations and more In forms you can use the knob instead of the touchscreen controls to navigate through most fields and lists as follows e Turn clockwise for the next field Turn counter clockwise for the previous field Press to select the highlighted field Entering text In forms and annotations you can enter text in text fields using the on screen keyboard To enter text using the on screen keyboard 1 Tapatext field The on screen keyboard appears with the text
65. ncreased electromagnetic emissions or decreased immunity use Manufacturer s declaration only accessories and peripherals recommended by SonoSite Connection of accessories and peripherals not recommended by SonoSite could result in malfunctioning of your ultrasound system or other medical electrical devices in the area Contact SonoSite or your local representative for a list of accessories and peripherals available from or recommended by SonoSite See the SonoSite accessories user guide Electrostatic discharge ESD or static shock is a naturally occurring phenomenon ESD is common in conditions of low humidity which can be caused by heating or air conditioning Static shock is a discharge of the electrical energy from a charged body to a lesser or non charged body The degree of discharge can be significant enough to cause damage to a transducer or an ultrasound system The following precautions can help reduce ESD anti static spray on carpets anti static spray on linoleum and anti static mats Table 1 and Table 2 document the intended use environment and EMC compliance levels of the system For maximum performance ensure that the system is used in the environments described in this table The system is intended for use in the electromagnetic environment specified below Table 1 Manufacturer s Declaration Electromagnetic Emissions Emissions Test Compliance Electromagnetic Environment RF emissions Group 1 The SonoSi
66. nd disinfectant contact duration Wipe surfaces with the disinfectant solution Air dry or towel dry with a clean cloth Examine the transducer and cable for damage such as cracks splitting or fluid leaks If damage is evident discontinue use of the transducer and contact SonoSite or your local representative Cleaning and disinfecting To clean and disinfect a transducer immersion method 1 2 3 Disconnect the transducer from the system Remove any transducer sheath Clean the surface using a soft cloth lightly dampened in a mild soap or compatible cleaning solution to remove any particulate matter or body fluids Apply the solution to the cloth rather than the surface Rinse with water or a wipe with water dampened cloth and then wipe with a dry cloth Mix the disinfectant solution compatible with the transducer following disinfectant label instructions for solution strengths and disinfectant contact duration Immerse the transducer into the disinfection solution not more than 12 18 inches 31 46 cm from the point where the cable enters the connector Follow the instructions on the disinfectant label for the duration of the transducer immersion Using the instructions on the disinfectant label rinse to the point of the previous immersion and then air dry or towel dry with a clean cloth Examine the transducer and cable for damage such as cracks splitting or fluid leaks If damage is eviden
67. nd is used for detecting the presence velocity and direction of blood flow Tissue Harmonic Imaging uses higher received frequencies to reduce clutter artifact and improve resolution on the 2D image Understanding the nature of the imaging mode used allows the qualified ultrasound user to apply the ALARA principle Prudent use of ultrasound requires that patient exposure to ultrasound be limited to the lowest ultrasound output for the shortest time necessary to achieve acceptable diagnostic results Decisions that support prudent use are based on the type of patient exam type patient history ease or difficulty of obtaining diagnostically useful information and potential localized heating of the patient due to transducer surface temperature The system has been designed to ensure that temperature at the face of the transducer will not exceed the limits established in Section 42 of EN 60601 2 37 Particular requirement for the safety of ultrasound medical diagnostic and monitoring equipment See Transducer surface temperature rise on page 50 In the event of a device malfunction there are redundant controls that limit transducer power This is accomplished by an electrical design that limits both power supply current and voltage to the transducer The sonographer uses the system controls to adjust image quality and limit ultrasound output The system controls are divided into three categories relative to output controls that directly affec
68. nnect the DC power cable from the power supply to its port on the dock See Figure 1 on page 1 3 Connect the AC power cord to the power supply and to a hospital grade electrical outlet Turning the system on or off Caution Do not use the system if an error message appears on the screen Note the error code and turn off the system Call SonoSite or your local representative To turn the system on or off Press the power switch See System front top and back bottom on page 1 To wake up the system To conserve battery life while the system is on the system goes into sleep mode if untouched for a preset time To adjust the time for sleep delay see Audio Battery setup on page 12 Tap the screen Connecting transducers WARNING To avoid injury to the patient do not place the connector on the patient Operate the ultrasound system in the V Universal Stand or on a convenient surface to allow air flow past the connector Caution To avoid damaging the transducer connector do not allow foreign material in the connector Chapter 1 Getting Started 3 peus bunya Figure 3 Connect the Transducer To connect a transducer 1 Pull the transducer latch up and rotate it clockwise 2 Align the transducer connector with the connect
69. nt ise nesana AEE EES EEES 17 Adjusting screen brightness sssssssssssssssssssesssssssssssesssesssesssrsreeerereeressnsssnsssssssessseese 18 Patient information form sssssccsssecsesssscccsseececssseessssueseccssseceessnsessssneeessssseeesesnsess 18 Patient information form fields estes 18 uror mee P REN 19 Saving images wld Reviewing patient exams ss we 19 Printing exporting and deleting images 1 20 Imaging modes and exams available by transducer 21 Chapter 4 Measurements and Calculations Measurements Working with calipers i WEEET E Calculations IMT exam wicccccccscsscsscsccssscesssescsstssssssssssscssssscsssessssessssssssssssssssesess Patient rEpOrt M Chapter 5 Troubleshooting and Maintenance Troubleshooting ttes iea EEEE Software licensing i MET Cleaning and disinfecting sssecsssscssssecssssessssecssssssssscsssuecsssscessuecssssccssuecsssneeesseess 28 Cleaning and disinfecting the ultrasound system 28 Cleaning and disinfecting transducers s 29 Cleaning and disinfecting the battery or dock 31 Chapter 6 Safety is fo Tefafor ties ee RC 33 Position the system cesssecsssccssecssecsssscssccssscssssssscessecss
70. ogy Third Edition published by the American Institute of Ultrasound in Medicine AIUM as low as reasonably The guiding principle of ultrasound use which states that you should achievable ALARA curved array transducer depth in situ LCD linear array transducer mechanical index MI MI TI NTSC PAL phased array keep patient exposure to ultrasound energy as low as reasonably achievable for diagnostic results Identified by the letter C curved or curvilinear and a number for example 60 The number corresponds to the radius of curvature of the array expressed in millimeters The transducer elements are electrically configured to control the characteristics and direction of the acoustic beam For example C11n C60n Refers to the depth of the display A constant speed of sound of 1538 5 meters second is assumed in the calculation of echo position in the image In the natural or original position liquid crystal display Identified by the letter L linear and a number for example 38 The number corresponds to the radius of width of the array expressed in millimeters The transducer elements are electrically configured to control the characteristics and direction of the acoustic beam For example L38n An indication of the likelihood of mechanical bioeffects occurring the higher the MI the greater the likelihood of mechanical bioeffects See Chapter 6 Safety for a more complete description of
71. ol 5 MB Multi Beam Off On a This index is not required for this operating mode value is lt 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition since the global maximum index value is not reported for the reason listed Reference Global Maximum Index Value line Data are not applicable for this transducer mode Chapter 6 Safety 59 Ayayes Table 17 Transducer Model P21n 5 1 Operating Mode CPD Color TIS TIB Index Label MI Non scan TIC Scan Non scan AaprtS1 Aaprt gt 1 Global Maximum Index Value 1 5 1 2 2 4 Pr3 MP 2 15 Wo mW 105 7 177 9 E min of W 5 z1 l4 3 z1 mW 5 oiz cm i S 5 cm 9 S Zz cm 4 9 Sog P day cm i MHz 2 15 2 15 2 15 Dim of Aaprt X cm 0 92 1 97 Y cm 1 3 1 3 PD use 0 85 S PRF H 1126 E p GPIl as MP 2 835 S degGPlli cm Focal Length FL cm 6 43 13 84 E FLy cm 5 5 us 5 5 Ipa 3 Mlmax W cm 367 2 Control 1 Mode CPD or Color Color Color E 2 Control 2 Exam Type Abd Cardiac Cardiac V amp Control 3 2D Optimization Gen or oZ Pen Gen Pen Q Control 4 Depth 4 7 cm 5 cm 30 cm amp Control 5 THI On Off Off Control 6 Color Box Default Default Default a This index is n
72. on Security settings on the system allow you to meet the applicable security requirements listed in the HIPAA standard Users are ultimately responsible for ensuring the security and protection of all electronic protected health information collected stored reviewed and transmitted on the system To log in as Administrator 1 Onthe Administration setup page type Administrator in the Name box See Entering text on page 6 Chapter 2 System Setup 9 dnjas 2 Type the administrator password in the Password box If you need the administrator password contact SonoSite See SonoSite Technical Support on page vii 3 Tap Login To log out as Administrator Turn off or restart the system To require user login You can set the system to display the User Login screen at startup 1 Login as Administrator 2 Inthe User Login list select On Onrequires a user name and password at startup e Off allows access to the system without a user name and password To change the administrator password or let users change passwords 1 Login as Administrator 2 Under User List select Administrator 3 Do any of the following Change the administrator password Under User Information type the new password in the Password box and Confirm box See Choosing a secure password on page 11 Let users change their passwords Select the Password changes check box 4 Tap Save User setup To ad
73. onduct a safe system shutdown always keep a battery in the system To install the battery 1 Disconnect the power supply from the ultrasound system 2 Slide the two pronged end of the battery into the end of the battery compartment near the handle 3 Push down on the locking lever until the battery snaps securely in place To remove the battery 1 Disconnect the power supply from the ultrasound system 2 Holding the system backside down carefully push down the locking lever and catch the battery as it drops from the compartment Using AC power and charging the battery The battery charges when the system is connected to the AC power supply A fully discharged battery recharges in less than five hours The system can run on AC power and charge the battery if AC power is connected to the system The system can run on battery power for up to two hours depending on the imaging mode and the display brightness When running on battery power the system may not restart if the battery is low To continue connect the system to AC power If users in the United States connect the equipment to a 240V supply system the equipment shall be connected to a center tapped single phase supply circuit WARNING Caution Verify that the hospital supply voltage corresponds to the power supply voltage range See Electrical on page 72 To operate the system using AC power 1 Connect the dock to the system 2 Co
74. or on the back of the system and insert the transducer 3 Turn the latch counter clockwise 4 Press the latch down securing the transducer connector to the system To remove a transducer 1 Pull the transducer latch up and rotate it clockwise 2 Pullthe transducer connector away from the system 4 About the system Inserting and removing USB storage devices Images save to internal storage and are organized in a sortable patient list You can archive the images from the ultrasound system to a PC using a USB storage device Although the images cannot be viewed from a USB storage device on the ultrasound system you can remove the device and view them on your PC You can also import and export user accounts and the Event log using a USB storage device Note SonoSite supports the USB storage device included optionally with the system Other brands are untested and may not perform as expected WARNING To avoid damaging the USB storage device and losing patient data from it observe the following Do not remove the USB storage device or turn off the ultrasound system while the system is exporting Do not bump or otherwise apply pressure to the USB storage device while it is in a USB port on the ultrasound system The connector could break Caution If the USB icon does not appear in the system status area on screen the USB storage device may be defective or password protected Turn the system off and replac
75. ort See SonoSite Technical Support on page vii Maintenance Use the recommendations in this document when cleaning or disinfecting the ultrasound system transducer and accessories Use the cleaning recommendations in the peripheral manufacturer s instructions when cleaning or disinfecting peripherals No periodic or preventive maintenance is required for the system transducer or accessories other than cleaning and disinfecting the transducer after every use See Cleaning and disinfecting transducers on page 29 There are no internal components that require periodic testing or calibration All maintenance requirements are described in this chapter and in the ultrasound system service manual Performing maintenance procedures not described in the user guide or service manual may void the product warranty Contact SonoSite Technical Support for any maintenance questions See SonoSite Technical Support on page vii 28 Maintenance WARNING The level of disinfection required for a device is dictated by the type of tissue it will contact during use To avoid infection ensure that the disinfectant type is appropriate for the equipment For information see the disinfectant label instructions and the recommendations of the Association for Professionals in Infection Control and Epidemiology APIC and the FDA To prevent contamination the use of sterile transducer sheaths and sterile coupling gel is
76. ot required for this operating mode value is lt 1 b This transducer is not intended for transcranial or neonatal cephalic uses No data are reported for this operating condition since the global maximum index value is not reported for the reason listed Reference Global Maximum Index Value line Data are not applicable for this transducer mode 60 Terms used in the acoustic output tables Table 18 Acoustic Output Terms and Definitions Term Definition lspra 3 Derated spatial peak temporal average intensity in units of milliwatts cm Tl type Applicable thermal index for the transducer imaging mode and exam type TI value Thermal index value for the transducer imaging mode and exam type MI Mechanical index Ipa 3 MImax Derated pulse average intensity at the maximum MI in units of W cm TIS Soft tissue thermal index is a thermal index related to soft tissues TIS scan is the soft tissue thermal index in an auto scanning mode TIS non scan is the soft tissue thermal index in the non autoscanning mode TIB Bone thermal index is a thermal index for applications in which the ultrasound beam passes through soft tissue and a focal region is in the immediate vicinity of bone TIB non scan is the bone thermal index in the non autoscanning mode TIC Cranial bone thermal index is the thermal index for applications in which the ultrasound beam passes through bone near the beam entrance into the body Aaprt Area of
77. ot use a surgeon s brush when cleaning transducers Even the use of soft brushes can damage a transducer Use a soft cloth Using a non recommended cleaning or disinfection solution using incorrect solution strength or immersing a transducer deeper or for a longer period of time than recommended can damage or discolor the transducer and void the transducer warranty Do not allow cleaning solution or disinfectant into the transducer connector Chapter 5 Troubleshooting and Maintenance 29 Bunoouse qnoJ Caution Do not allow disinfectant to contact metal surfaces Use a soft cloth lightly dampened in a mild soap or compatible cleaning solution to remove any disinfectant that remains on metal surfaces Attempting to disinfect a transducer or transducer cable using a method other than the one included here can damage the transducer and void the warranty To clean and disinfect a transducer wipe method 1 2 3 30 Disconnect the transducer from the system Remove any transducer sheath Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning solution to remove any particulate matter or body fluids Apply the solution to the cloth rather than the surface Rinse with water or wipe with water dampened cloth and then wipe with a dry cloth Mix the disinfectant solution compatible with the transducer following disinfectant label instructions for solution strengths a
78. pability system setup and scanning technique is necessary The imaging mode determines the nature of the ultrasound beam A stationary beam results in a more concentrated exposure than a scanned beam which spreads that exposure over that area The transducer capability depends upon the frequency penetration resolution and field of view The default system presets are reset at the start of each new patient It is the scanning technique of the qualified ultrasound user along with patient variability that determines the system settings throughout the exam The variables which affect the way the qualified ultrasound user implements the ALARA principle include patient body size location of the bone relative to the focal point attenuation in the body and ultrasound exposure time Exposure time is an especially useful variable because the qualified ultrasound user can control it The ability to limit the exposure over time supports the ALARA principle Applying ALARA The system imaging mode selected by the qualified ultrasound user is determined by the diagnostic information required 2D imaging provides anatomical information CPD imaging provides information about the energy or amplitude strength of the Doppler signal over time at a given anatomical location and is used for detecting the presence of blood flow Color imaging provides information about the energy or amplitude strength of the Doppler signal over time at a given anatomical location a
79. pper limits less than 1 and 4 C 1 8 and 7 2 F for exposures of first trimester fetal tissue and second trimester fetal bone respectively The largest values obtained were approximately 1 5 C 2 7 F for first trimester fetal tissue and 7 C 12 6 F for second trimester fetal bone Estimated maximum temperature elevations given here are for a fixed path tissue model and are for devices having Ispra values greater than 500 mW cm The temperature elevations for fetal bone and tissue were computed based on calculation procedures given in Sections 4 3 2 1 4 3 2 6 in Bioeffects and Safety of Diagnostic Ultrasound AIUM 1993 Global Maximum Acoustic Outputs 52 The following tables summarize the expected range of global maximum acoustic output values for each transducer model and imaging mode The values are based on a statistical sample test of early production transducers to determine the expected variability of acoustic outputs The values in the tables are determined with 90 confidence that 90 of the transducer system combinations generate an acoustic output less than the maximum and greater than the minimum values Table 7 Transducer Model C11n 8 5 Global Maximum Mode of Operation Output Levels 2D Color CPD max IsPTA 3 21 58 min IcPTA 3 15 40 max MI 0 68 0 70 min MI 0 58 0 56 max TIS 0 41 0 72 min TIS 0 29 0 50 max TIB 041 072 min TIB 0 29 0 50 max TIC 0 67 0 99 min TIC 0 46 0 69 Table 8 Transducer Mode
80. rce such as a fire or heater Do not leave the battery in direct sunlight Do not pierce the battery with a sharp object hit it or step on it Do not use a damaged battery Do not solder a battery The polarity of the battery terminals are fixed and cannot be switched or reversed Do not force the battery into the system Do not connect the battery to an electrical power outlet WARNING Caution Do not continue recharging the battery if it does not recharge after two successive six hour charging cycles If the battery leaks or emits an odor remove it from all possible flammable sources Do not immerse the battery in water or allow it to get wet Do not put the battery into a microwave oven or pressurized container If the battery emits an odor or heat is deformed or discolored or in any way appears abnormal during use recharging or storage immediately remove it and stop using it If you have any questions about the battery consult SonoSite or your local representative Store the battery between 20 C 4 F and 60 C 140 F Use only SonoSite batteries Do not use or charge the battery with non SonoSite equipment Only charge the battery with the system Dispose of the battery in accordance with local regulations Clinical safety WARNING Non medical commercial grade peripheral monitors have not been verified or validated by SonoSite as being suitable for diagnosis To avoid the risk of a burn
81. rs are TIS Auto save Pat Form Automatically saves the patient information form as an image in the patient s file Unfreeze You can specify which text from annotations to keep when you unfreeze an image or change the imaging layout Select Keep All Text Keep Home Text or Clear All Text The default setting is Keep All Text See also To reset the home position on page 17 Language The system language Changing the language requires restarting the system To calibrate the touchscreen If the touchscreen s response seems out of alignment or imprecise you can calibrate the touchscreen On the Presets setup page tap Calibrate for Touchscreen and follow the on screen instructions System Information setup The System Information setup page displays patents system hardware and software versions and license information See also To enter a license key on page 28 USB Devices setup On the USB Devices setup page you can view information about connected USB devices including space availability You can also specify a file format for images in patient exams that you export to a USB storage device If exporting images for DICOM use you can specify the AE title Application Entity title Chapter 2 System Setup 13 dnjas To specify a file format for exported images 1 On the USB Devices setup page tap Export 2 Under USB Export select an export type e SiteLink organizes files ina SiteLink
82. s organized in columns with Name ID Date Time and number of images saved Date Time v Name PATIENT1 2010Dec15 04 06 PATIENT2 2010Dec1S 04 06 PATIENTS 20100ec15 04 07 Select All Review Figure 1 Patient List To display the patient list 1 In 2D tap More and select Review 2 If there is a current patient tap List To sort the patient list After the system starts the patient list is arranged by date and time with the most recent patient exam first You can re sort the patient list as needed Tap the column heading that you want to sort by Tap it again if sorting in reverse order Note The selection column v4 is sortable To select patient exams in the patient list Tap one or more patient exams Tapping Select All selects all patient exams Selected patient exams have a check mark in the first column To deselect patient exams tap them or tap Clear All Chapter 3 Imaging 19 To edit patient information from the patient list You can edit the patient name and ID from the patient list instead of from the patient information form if the exam is closed but has not been exported 1 Inthe patient list select the patient exam 2 Tap Edit 3 Fill in the form fields and tap OK To append images to a patient exam Although you cannot add images to a patient exam that is ended exported or archived you can automatically start a new patient exam that has the same patient information Dep
83. s battery life To conserve battery life adjust brightness to a lower setting To adjust the screen brightness In 2D imaging tap ie and then turn the knob Patient information form WARNING To avoid misdiagnosis caused by confusing the images from multiple patients make sure to enter patient ID patient name or both in the patient information form The patient information form lets you enter patient identification exam and clinical information for the patient exam This information automatically appears in the patient report When you create a new patient information form all images and other data you save during the exam are linked to that patient See Patient report on page 26 To create a new patient information form Note Creating a new patient information form erases any unsaved patient information including calculations and report page To save this information save the screen for each item 1 Tap Patient 18 Adjusting screen brightness 2 Tap New End 3 Fill in the form fields See Patient information form fields on page 18 and Entering text on page 6 4 Tap Done See also To append images to a patient exam on page 20 To edit a patient information form You can edit patient information if the exam has not been exported See also To edit patient information from the patient list on page 20 1 In2D tap Patient 2 Make changes as desired 3 Tapone ofthe follo
84. some transducer materials SonoSite recommends Aquasonic gel and provides a sample with the system For general use apply a liberal amount of gel between the transducer and the body For invasive or surgical use apply a transducer sheath WARNING To prevent contamination the use of sterile transducer sheaths and sterile coupling gel is recommended for clinical applications of an invasive or surgical nature Do not apply the transducer sheath and gel until you are ready to perform the procedure To apply a transducer sheath SonoSite recommends the use of market cleared transducer sheaths for intracavitary or surgical applications To lessen the risk of contamination install the sheath only when you are ready to perform the procedure 1 Place gel inside the sheath 2 Insert the transducer into the sheath 3 Pullthe sheath over the transducer and cable until the sheath is fully extended 4 Secure the sheath using the bands supplied with the sheath 5 Check for and eliminate bubbles between the face of the transducer and the sheath Bubbles between the face of the transducer and the sheath may affect the ultrasound image 6 Inspect the sheath to ensure that there are no holes or tears Intended uses The system transmits ultrasound energy into various parts of the patient s body using 2D color Doppler Color and color power Doppler CPD to obtain ultrasound images as follows For the intended transdu
85. sscssecsecssecseesscesecssecsecssecsecsccaterseeseerseeneesees 50 In Situ derated and water value intensities 50 Tissue models and equipment survey 51 Global Maximum Acoustic Outputs 52 Acoustic output tables seisoessaan 54 Terms used in the acoustic output tables sss 61 Acoustic measurement precision and uncertainty 63 ADSI Ry indere RETE m 64 Chapter 7 References Measurement accuracy 1 essesssscnsecsecssersccnsessscnscessecssensesssenscessensesseenecescenseenecnseeneess 69 Sources of measurement errOrs v scccsssssssecsssssssssssssssssssssssesssssesssscesssssesssssessseseesees 69 Measurement publications IMT eese tenntennntnnttnnttnnntnns 69 Chapter 8 Specifications Supported transducers seecsesccssecssecsssecseecsscssscsenssesscesscssaceeseecsscssssesseessuessneceseeesseess 71 Imaging modes o esssesessssssseccseccssccssecenscessccsuecessesssecssecsusccsscesscssuecesscesucceasesacessecesacessses 71 nrr dj0s qe 71 IRCCOSSOMI OS s 71 Peripheral rissies nsira esponiet i oie oni EE LEEENA 71 Temperature and humidity limits eee 71 sirop 71 Shipping and storage Electrical brucia 72 Electromechanical safety standards 72 EMC standards classification 72 Airborne equipment standards
86. st is composed entirely of soft tissue When the path contains significant amounts Chapter 6 Safety 51 Ayayes of fluid as in many first and second trimester pregnancies scanned transabdominally this model may underestimate the In Situ acoustic exposure The amount of underestimation depends upon each specific situation Fixed path tissue models in which soft tissue thickness is held constant sometimes are used to estimate In Situ acoustic exposures when the beam path is longer than 3 cm and consists largely of fluid When this model is used to estimate maximum exposure to the fetus during transabdominal scans a value of 1 dB cm MHz may be used during all trimesters Existing tissue models that are based on linear propagation may underestimate acoustic exposures when significant saturation due to non linear distortion of beams in water is present during the output measurement The maximum acoustic output levels of diagnostic ultrasound devices extend over a broad range of values Asurvey of 1990 equipment models yielded MI values between 0 1 and 1 0 at their highest output settings Maximum MI values of approximately 2 0 are known to occur for currently available equipment Maximum MI values are similar for real time 2D and M Mode imaging Computed estimates of upper limits to temperature elevations during transabdominal scans were obtained in a survey of 1988 and 1990 pulsed Doppler equipment The vast majority of models yielded u
87. t discontinue use of the transducer and contact SonoSite or your local representative Cleaning and disinfecting the battery or dock Caution To avoid damaging the battery do not allow cleaning solution or disinfectant to come in contact with the battery terminals To clean and disinfect the battery or dock wipe method 1 Remove the battery or dock from the system 2 Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning solution Apply the solution to the cloth rather than the surface 3 Wipe the surfaces with the disinfection solution 4 Air dry or towel dry with a clean cloth Chapter 5 Troubleshooting and Maintenance 31 Bunoouse qnoJ 32 Cleaning and disinfecting Chapter 6 Safety This chapter contains information required by regulatory agencies including information about the ALARA as low as reasonably achievable principle the output display standard acoustic power and intensity tables and other safety information The information applies to the ultrasound system transducer accessories and peripherals Ergonomic safety These healthy scanning guidelines are intended to assist you in the comfort and effective use of your ultrasound system WARNING To prevent musculoskeletal disorders follow the guidelines in this section Use of an ultrasound system may be linked to musculoskeletal disorders Use of an ultrasound system is defined as the physical
88. t cables and power cords used within the system on a regular basis for damage To avoid the risk of electrical shock to the patient subject do not simultaneously touch the system battery contacts and the patient subject To prevent injury to the operator bystander the transducer must be removed from patient contact before the application of a high voltage defibrillation pulse To avoid possible electrical shock or electromagnetic interference verify proper operation and compliance with relevant safety standards for all equipment before clinical use Connecting additional equipment to the ultrasound system constitutes configuring a medical system SonoSite recommends verifying that the system all combinations of equipment and accessories connected to the ultrasound system comply with JACHO installation requirements and or safety standards such as AAMI ES1 NFPA 99 OR IEC Standard 60601 1 1 and electromagnetic compatibility standard IEC 60601 1 2 Electromagnetic compatibility and are certified according to IEC Standard 60950 Information Technology Equipment ITE Do not use the system if an error message appears on the image display note the error code call SonoSite or your local representative turn off the system by pressing and holding the power key until the system powers down To avoid increasing the system and transducer connector temperature do not block the airflow to the ventilation holes on the back of the system Chapter
89. t output controls that indirectly affect output and receiver controls Direct controls The system does not exceed a spatial peak temporal average intensity ISPTA of 720 mW cm for all imaging modes The mechanical index MI and thermal index TI may exceed values greater than 1 0 on some transducers in some imaging modes One may monitor the MI and TI values and adjust the controls to reduce these values See Guidelines for reducing MI and TT on page 46 Additionally one means for meeting the ALARA principle is to set the MI or TI values to a low index value and then modifying this level until a satisfactory image or Doppler mode is obtained For more information on MI and TI see BS EN 60601 2 37 2008 Annex HH Chapter 6 Safety 45 Ayayes Indirect controls The controls that indirectly affect output are controls affecting imaging mode freeze and depth The imaging mode determines the nature of the ultrasound beam Tissue attenuation is directly related to transducer frequency The higher the PRF pulse repetition frequency the more output pulses occur over a period of time Receiver controls The receiver controls are the gain controls Receiver controls do not affect output They should be used if possible to improve image quality before using controls that directly or indirectly affect output Acoustic artifacts An acoustic artifact is information present or absent in an image that does not properly indicate the s
90. te of manufacture Direct Current DC Do not get wet Do not stack over 2 high Do not stack over 5 high Do not stack over 10 high Electrostatic sensitive devices Device complies with relevant FCC regulations for electronic devices Fragile Gel sterilized by radiation Chapter 6 Safety 65 Ayayes 66 Table 20 Labeling Symbols Continued Symbol Definition Hot Device emits a static DC magnetic field Non ionizing radiation Paper recycle Serial number type of control number Storage temperature conditions Submersible Protected against the effects of temporary immersion Handle transducer with care Type BF patient applied part B body F floating applied part Underwriter s Laboratories labeling Pollution Control Logo Number in the center may vary Applies to all parts products listed in the China RoHS disclosure table May not appear on the exterior of some parts products because of space limitations China Compulsory Certificate mark CCC Mark A compulsory safety mark for compliance to Chinese national standards for many products sold in the People s Republic of China Contains mercury Applies to the LCD and may apply to other components in the ultrasound system Table 20 Labeling Symbols Continued Symbol Definition WARNING Connect Only Accessories and Peripherals Recommended by SonoSite WARNING Connect Only
91. te ultrasound system uses RF energy only CISPR 11 for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class A The SonoSite ultrasound system is suitable for use in CISPR 11 all establishments other than domestic and those directly connected to the public low voltage power supply network which supplies buildings used for domestic purposes Harmonic emissions Class A IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 Chapter 6 Safety 41 Ayayes The system is intended for use in the electromagnetic environment specified below Table 2 Manufacturer s Declaration Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Electrostatic Discharge ESD IEC 61000 4 2 Electrical fast Transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 2 0KV 4 0KV 6 0KV contact 2 0KV 4 0KV 8 0KV air 2KV on the mains 1KV on signal lines 0 5KV 1 0KV 2 0KV on AC power lines to ground 0 5KV 1 0KV on AC power lines to lines gt 5 Ur gt 95 dip in Ur for 0 5 cycle 4096 Ur 6096 dip in Ur for 5 cycles 7096 Ur 30 dip in U7 for 25 cycles 2596 Ur 29596 dip in Ur for 5s 2 0KV 4 0KV 6 0KV contact 2 0
92. that high levels of radiated or conducted radio frequency electromagnetic interference EMI from portable and mobile RF communications equipment or other strong or nearby radio frequency sources could result in performance disruption of the ultrasound system Evidence of disruption may include image degradation or distortion erratic readings equipment ceasing to operate or other incorrect functioning If this occurs survey the site to determine the source of disruption and take the following actions to eliminate the source s e Turn equipment in the vicinity off and on to isolate disruptive equipment e Relocate or re orient interfering equipment Increase distance between interfering equipment and your ultrasound system e Manage use of frequencies close to ultrasound system frequencies Remove devices that are highly susceptible to EMI Lower power from internal sources within facility control such as paging systems Label devices susceptible to EMI Educate clinical staff to recognize potential EMI related problems Eliminate or reduce EMI with technical solutions such as shielding e Restrict use of personal communicators cell phones computers in areas with devices susceptible to EMI Share relevant EMI information with others particularly when evaluating new equipment purchases which may generate EMI Purchase medical devices that comply with IEC 60601 1 2 EMC Standards Caution To avoid the risk of i
93. the US call the nearest SonoSite representative You can also e mail SonoSite at comments sonosite com For technical support please contact SonoSite as follows SonoSite Technical Support Phone 877 657 8118 US or Canada Phone 425 951 1330 Outside US and Or call your local Canada representative Fax 425 951 6700 E mail service sonosite com Web site www sonosite com Click Resources gt Support amp Service 44 0 1462 444 800 uk service sonosite com Europe Service Center vii uon npoanu viii Customer comments Chapter 1 Getting Started About the system The NanoMaxx ultrasound system is a portable software controlled device that acquires and displays high resolution real time ultrasound images Features available on your system depend on the configuration transducer and exam type You need a license key to activate the software See Software licensing on page 27 Basic steps 1 Turn the system on 2 Attach a transducer 3 Tap Patient and complete the patient information form 4 Ifyou want Color imaging tap Color By default the system is in 2D imaging Figure 1 System front top and back bottom Handle Knob Power switch Touchscreen Battery compartment USB ports on side Transducer compartment Fold out leg oO OD N
94. the depth in all imaging modes The vertical depth scale is marked in 0 5 cm 1 cm and5 cm increments depending on the depth To change the style of depth markers see Presets setup on page 13 Tap Ay and turn the knob Clockwise increases the displayed depth e Counterclockwise decreases the displayed depth To adjust gain automatically Tap Auto Gain The gain adjusts each time you tap the control To adjust gain manually 2D 1 Tap Gain to select a setting Gain adjusts the overall gain applied to the entire image Near adjusts the gain applied to the near field of the 2D image Faradjusts the gain applied to the far field of the 2D image 16 Adjusting depth and gain 2 Turn the knob e Clockwise increases gain e Counterclockwise decreases gain To adjust gain manually Color CPD Tap b Gain and turn the knob e Clockwise increases gain e Counterclockwise decreases gain This control affects the color gain applied to the ROI box To revert to the default 2D gain setting Tap Reset This control may be on a page different from the gain controls Freezing viewing frames and zooming To freeze or unfreeze an image Tap Freeze or Unfreeze To move forward or backward in the cine buffer 1 Freeze the image 2 Tap b The number of frames appears below the cine icon 3 Turn the knob The number below the icon changes to reflect the frame displayed To
95. ton cloth with an ethanolic based liquid cleaner and wipe the screen clean Apply the cleaner to the cloth rather than the surface of the screen To clean and disinfect system surfaces 1 2 Turn off the system Disconnect the system from the power supply or remove it from the stand Clean the exterior surfaces using a soft cloth lightly dampened in a mild soap or detergent cleaning solution to remove any particulate matter or body fluids Apply the solution to the cloth rather than the surface Mix the disinfectant solution compatible with the system following disinfectant label 5 6 instructions for solution strengths and disinfectant contact duration Wipe surfaces with the disinfectant solution Air dry or towel dry with a clean cloth Cleaning and disinfecting transducers To disinfect the transducer and its cable use the immersion method or the wipe method Immersible transducers can be disinfected only if the product labeling indicates they can be used with an immersion method WARNING Caution To avoid electrical shock before cleaning disconnect the transducer from the system To avoid injury always use protective eyewear and gloves when performing cleaning and disinfecting procedures Transducers must be cleaned after every use Cleaning transducers is necessary prior to effective disinfection Ensure that you follow the manufacturer s instructions when using disinfectants Do n
96. tructure or flow being imaged There are helpful artifacts that aid in diagnosis and those that hinder proper interpretation Examples of artifacts include Shadowing Through transmission Aliasing Reverberations Comet tails For more information on detecting and interpreting acoustic artifacts see the following reference Kremkau Frederick W Diagnostic Ultrasound Principles and Instruments 7th ed W B Saunders Company Oct 17 2005 Guidelines for reducing MI and TI 46 The following are general guidelines for reducing MI or TI If multiple parameters are given the best results may be achieved by minimizing these parameters simultaneously In some modes changing these parameters does not affect MI or TI Changes to other parameters may also result in MI and TI reductions Please note the MI and TI values on the right side of the screen Table 3 MI Transducer Depth Clin T C60n T L25n T L38n T P21n T V Decrease or lower setting of parameter to reduce MI 1 Increase or raise setting of parameter to reduce MI Table 4 TI TIS TIC TIB CPD Settings Transducer Bok Depth Depth Optimize Clin i i C60n 1 T L25n L38n P21n T V Decrease or lower setting of parameter to reduce TI 1 Increase or raise setting of parameter to reduce Tl Data are not applicable Chapter 6 Safety 47 Ayayes Output display The system meets the AIUM output display standard for MI and TI s
97. uency magnetic fields or to install magnetic shielding The power frequency magnetic field should be measured in the Intended installation location to assure that it is sufficiently low Portable and mobile RF communications equipment should be used no closer to any part of the SonoSite ultrasound system including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance d 1 2 P d 1 2 P 80 MHz to 800 MHz d 2 3 JP 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and dis the recommended separation distance in meters m Chapter 6 Safety 43 Ayayes Table 2 Manufacturer s Declaration Electromagnetic Immunity Continued Electromagnetic Immunity Test IEC 60601 Test Level Compliance Level Environment Radiated RF Field strengths from fixed RF IEC 61000 4 3 transmitters as determined by an electromagnetic Site survey should be less than the compliance level in each frequency range continued Interference may occur in the vicinity of equipment marked with the following symbol IEC 60417 No 417 IEC 5140 Source of non ionizing radiation Note Ur is the AC mains voltage prior to application of the test level At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not
98. ult for the TI is stated statistically With 95 confidence 9576 of the measured TI values will be within 21 to 4076 of the displayed TI value or 0 2 of the displayed value whichever value is larger The values equate to 1dB to 3dB A displayed value of 0 0 for MI or TI means that the calculated estimate for the index is less than 0 05 Factors that contribute to display uncertainty The net uncertainty of the displayed indices is derived by combining the quantified uncertainty from three sources measurement uncertainty system and transducer variability and engineering assumptions and approximations made when calculating the display values Measurement errors of the acoustic parameters when taking the reference data are the major source of error that contributes to the display uncertainty The measurement error is described in Acoustic measurement precision and uncertainty on page 63 The displayed MI and TI values are based on calculations that use a set of acoustic output measurements that were made using a single reference ultrasound system with a single reference transducer that is representative of the population of transducers of that type The reference system and transducer are chosen from a sample population of systems and transducers taken from early production units and they are selected based on having an acoustic output that is representative of the nominal expected acoustic output for all transducer system combin
99. ustic Output Indices on Diagnostic Ultrasound Equipment NEMA UD3 2004 Guidance on the interpretation of TI and MI to be used to inform the operator Annex HH BS EN 60601 2 37 Chapter 6 Safety 49 Ayayes Transducer surface temperature rise Table 6 lists the measured surface temperature rise from ambient 23 C 3 C of transducers used on the ultrasound system The temperatures were measured in accordance with EN 60601 2 37 section 42 with controls and settings positioned to give maximum temperatures Table 6 Transducer Surface Temperature Rise External Use C Test C11n C60n L25n L38n P21n Still air 15 3 15 9 15 8 14 8 16 6 Simulated use 8 5 9 1 9 7 9 4 9 1 Acoustic output measurement Since the initial use of diagnostic ultrasound the possible human biological effects bioeffects from ultrasound exposure have been studied by various scientific and medical institutions In October 1987 the American Institute of Ultrasound in Medicine AIUM ratified a report from its Bioeffects Committee Bioeffects Considerations for the Safety of Diagnostic Ultrasound J Ultrasound Med Sept 1988 Vol 7 No 9 Supplement The report sometimes referred to as the Stowe Report reviewed available data on possible effects of ultrasound exposure Another report Bioeffects and Safety of Diagnostic Ultrasound dated January 28 1993 provides more current information The acoustic output for this ultrasound system has been
100. ving rise to the reported value of MI in Hertz p GPll jax Peak rarefactional pressure at the point where the free field spatial peak pulse intensity integral is a maximum in Megapascals deq Pllmax Equivalent beam diameter at the point where the free field spatial peak pulse intensity integral is a maximum in centimeters FL Focal length or azimuthal x and elevational y lengths if different measured in centimeters Acoustic measurement precision and uncertainty All table entries have been obtained at the same operating conditions that give rise to the maximum index value in the first column of the table Measurement precision and uncertainty for power pressure intensity and other quantities that are used to derive the values in the acoustic output table are shown in the table below In accordance with Section 6 4 of the Output Display Standard the following measurement precision and uncertainty values are determined by making repeat measurements and stating the standard deviation as a percentage Table 19 Acoustic Measurement Precision and Uncertainty Quantity Pr Pr3 Wo fc PII PII 3 Precision of standard deviation 1 996 1 996 3 496 0 196 3 296 3 296 Uncertainty 9596 confidence 11 2 12 2 10 4 7 12 5 to 16 8 13 47 to 17 5 Chapter 6 Safety 63 Ayayes Labeling symbols The following symbols are used on the products packaging and containers 64 Table 20 Label
101. wing Cancel to undo changes and return to imaging Doneto save changes and return to imaging To end the exam 1 Make sure that you have saved images and other data you want to keep See Images on page 19 2 In2D tap Patient 3 Tap New End A new patient information form appears Patient information form fields Patient e Last First Middle Patient name e ID Patient identification number Accession Enter number if applicable Gender e Date of birth Exam Type Exam types available depend on transducer See Imaging modes and exams available by transducer on page 21 BP Blood pressure IMT exam HRHeart rate IMT exam Ethnicity IMT exam Other User Institution Images Saving images When you save an image the image saves to internal storage The system beeps if Beep Alert is on and the percentage icon flashes See Audio Battery setup on page 12 The percentage icon shows the percentage of space available in internal storage To access saved images display the patient list See Reviewing patient exams To save an image Tap Save Reviewing patient exams Caution If the internal storage icon does not appear in the system status area internal storage may be defective Contact SonoSite Technical Support See SonoSite Technical Support on page vii The patient list lets you organize saved images from a central location The patient list i
102. y quality properly adjust the screen brightness center and bandwidth and gain depth and viewing angle Also use a waveform suitable optimization setting and exam type THI Turns Tissue Harmonic Imaging on and off When Tissue Harmonic Imaging is on THI appears on screen This feature is e Turn on the system optional and depends on transducer and exam type MB On MB On and MB Off turn SonoMB MB Off technology on and off When SonoMB See 2D controls on page 15 and Adjusting technology is on MB appears depth and gain on page 16 on screen in the status area To display the 2D image 1 Do any of the following e Ifin Color imaging tap 2D 2 Adjust the image as needed See also Adjusting depth and gain on page 16 CPD and color Doppler imaging Color power Doppler CPD and color Doppler Color are optional features CPD is used to visualize the presence of detectable blood flow Color is used to visualize the presence velocity and direction of blood flow in a wide range of flow states Chapter 3 Imaging 15 To display the CPD or Color image 1 Tap Color A region of interest ROI box appears in the center of the 2D image 2 Tap CPD or Color on the left In Color imaging the Color indicator bar in the upper left hand screen displays velocity in cm s 3 Drag the ROI box as needed A green outline shows the change Adjusting depth and gain To adjust depth You can adjust

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